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IN.PACT Global Clinical Study

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
IN.PACT Admiral™ Drug Eluting Balloon
Sponsored by
Medtronic Endovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, Drug coated balloon, Superficial Femoral Artery, Popliteal Femoral Artery, Atherosclerosis, Drug eluting balloon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

General inclusion Criteria:

  • Age ≥ 18 years or minimum age as required by local regulations.
  • Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-4.
  • Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.

General exclusion Criteria:

  • High probability of non-adherence to Clinical Investigation Protocol follow-up requirements.
  • Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
  • Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.

Sites / Locations

  • Fundación Favaloro
  • Clinica La Sagrada Familia
  • Royal Prince Alfred Hospital
  • Medizinische Universität Graz
  • Landesklinikum Thermenregion Mödling
  • Onze-Lieve-Vrouwziekenuis
  • Imelda Ziekenhuis
  • AZ St. Blasius
  • Universitair Ziekenhuis Antwerpen
  • Ziekenhuis Oost Limburg - Campus St.-Jan
  • Universitair Ziekenhuis Gent
  • Regionaal Ziekenhuis Heilig Hart
  • Centre hospitalier universitaire Sherbrooke (CHUS)
  • Toronto General Hospital
  • Clinica Santa Maria
  • Clinica Medilaser Neiva
  • Faculty Hospital Hradec Kralove
  • As-Salam International Hospital
  • Egypt Air Hospital
  • Helsingin Seudun Yliopistollinen Keskussairaala
  • Group Hospitalier Pellegrin - CHU
  • Les Hospitaux Universitaires de Strasbourg
  • Herzzentrum Bad Krozingen
  • Augusta-Krankenhaus
  • Augusta Krankenhaus
  • Universitätsklinikum Heidelberg
  • Universitatsklinikum Leipzig AoR
  • Park-Krankenhaus Leipzig
  • St. Franziskus Hospital GmbH
  • RoMed Klinikum Rosenheim
  • Universitätsklinikum Tübingen
  • University Hospital of Patras
  • Semmelweis University
  • Bacs Kiskun Megyei Korhaz
  • Carmel Medical Centre
  • Rabin Medical Center - Beilison Hospital
  • Policlinico Vittorio Emanuele
  • Maria Eleonora Hospital
  • Policlinico Gemelli
  • Severence Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Korea University Guro Hospital
  • Ajou University Hospital
  • Kaunas Mecial University Clinic
  • Jeroen Bosch Ziekenhuis
  • Rijnstate Ziekenhuis
  • Catharina Ziekenhuis
  • Sint Antonius Hospital
  • Universitair Medisch Centrum Utrecht
  • Euromedic Medical Center
  • Samodzielny Publiczny Szpital Kliniczny Nr 2
  • Hospital Santa Marta
  • City Clinical Hospital named after M.E. Zhadkevich
  • Changi General Hospital
  • Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH)
  • Národný ústav srdcových a cievnych chorôb a.s. (NUSCH)
  • Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH)
  • University Medical Centre Maribor
  • Karolinska Universitetssjukhuset
  • Inselspital - Universitätsspial Bern
  • Hopital Cantonal HFR
  • Kantonspital Luzern
  • Manchester Royal Infirmary
  • Northern General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IN.PACT Admiral DEB

Arm Description

The subjects in this trial will be treated with the IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon (hereinafter referred as "IN.PACT Admiral™ DEB")manufactured by Medtronic. The IN.PACT Admiral™ is a CE (Conformité Europeénne, European Confirmity) marked medical device utilized within its intended use in the IN.PACT Global trial.

Outcomes

Primary Outcome Measures

Clinical Cohort ITT - Primary Effectiveness Endpoint
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Primary Safety Endpoint
A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.
Imaging Cohort ITT - Primary Effectiveness Endpoint
Primary Patency within 12 months post-index procedure, which is defined as: Freedom from clinically-driven TLR and Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4. Restenosis determined by either PSVR >2.4 as assessed by an independent DUS core lab or >50% stenosis as assessed by an independent angiographic core lab.
150mm DEB ITT Cohort - Primary Effectiveness Endpoint
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.

Secondary Outcome Measures

Clinical Cohort ITT - MAEs
MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Clinical Cohort ITT - TVR
Any Target vessel revascularisation
Clinical Cohort ITT - Device Success
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
Clinical Cohort ITT - Clinical Success
Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
Clinical Cohort ITT - MAEs
MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - TVR
Clinical Cohort ITT - TLR
Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)
Clinical Cohort ITT - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.
All-cause mortality is reported by using the survival estimate of all cause mortality through 60 months
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure
Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Clinical Cohort ITT - Procedural Success
Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 6 months.
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 12 months.
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 24 months.
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 36 months.
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 48 months.
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 60 months.
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)
150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure.
All-cause mortality is reported by using the survival estimate of all-cause mortality through 60 months
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure
Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
150mm DEB ITT Cohort - Device Success
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
150mm DEB ITT Cohort - Procedural Success
Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate
150mm DEB ITT Cohort - Clinical Success
Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
Clinical Cohort ITT - All-cause Mortality
Clinical Cohort ITT - All-cause Mortality
Clinical Cohort ITT - All-cause Mortality
Clinical Cohort ITT - All-cause Mortality
Clinical Cohort ITT - All-cause Mortality
Clinical Cohort ITT - All-cause Mortality
Clinical Cohort ITT - All-cause Mortality
The difference in death count calculation between the compliance table (participant flow: 253 deaths) and the event table (244 deaths) is explained as follow: Calendar days (365/year) is used for compliance table whereas 360-day annual cutoff is used for event rate calculation Compliance table used visit window as specified by protocol (60 days for 5-year follow-up) whereas, not window is used for event rate calculation Nine patients died between 1801 and 1885 (1825 + 60) and were therefore not included in the 5-year death rate summary but were included in the compliance summary for patients that died through the upper window of the 60 month visit. The denominator of 1215 for 1800-day event rate includes those who had an event within 1800 days and those who did not have any event but had at least 1740 days of follow-up (1740 is the low bound of the 60-day visit window from the target day of 1800)
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Clinical Cohort ITT - Major Target Limb Amputation
Clinical Cohort ITT - Major Target Limb Amputation
Clinical Cohort ITT - Major Target Limb Amputation
Clinical Cohort ITT - Major Target Limb Amputation
Clinical Cohort ITT - Major Target Limb Amputation
Clinical Cohort ITT - Major Target Limb Amputation
Clinical Cohort ITT - Major Target Limb Amputation
150mm DEB ITT Cohort - All-cause Mortality
150mm DEB ITT Cohort - All-cause Mortality
150mm DEB ITT Cohort - All-cause Mortality
150mm DEB ITT Cohort - All-cause Mortality
150mm DEB ITT Cohort - All-cause Mortality
150mm DEB ITT Cohort - All-cause Mortality
150mm DEB ITT Cohort - All-cause Mortality
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
150mm DEB ITT Cohort - Major Target Limb Amputation
150mm DEB ITT Cohort - Major Target Limb Amputation
150mm DEB ITT Cohort - Major Target Limb Amputation
150mm DEB ITT Cohort - Major Target Limb Amputation
150mm DEB ITT Cohort - Major Target Limb Amputation
150mm DEB ITT Cohort - Major Target Limb Amputation
150mm DEB ITT Cohort - Major Target Limb Amputation

Full Information

First Posted
May 24, 2012
Last Updated
March 2, 2021
Sponsor
Medtronic Endovascular
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1. Study Identification

Unique Protocol Identification Number
NCT01609296
Brief Title
IN.PACT Global Clinical Study
Official Title
The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
January 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.
Detailed Description
Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia (CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death. The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Peripheral Arterial Disease, Drug coated balloon, Superficial Femoral Artery, Popliteal Femoral Artery, Atherosclerosis, Drug eluting balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1535 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IN.PACT Admiral DEB
Arm Type
Experimental
Arm Description
The subjects in this trial will be treated with the IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon (hereinafter referred as "IN.PACT Admiral™ DEB")manufactured by Medtronic. The IN.PACT Admiral™ is a CE (Conformité Europeénne, European Confirmity) marked medical device utilized within its intended use in the IN.PACT Global trial.
Intervention Type
Device
Intervention Name(s)
IN.PACT Admiral™ Drug Eluting Balloon
Intervention Description
IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.
Primary Outcome Measure Information:
Title
Clinical Cohort ITT - Primary Effectiveness Endpoint
Description
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
12 months
Title
Clinical Cohort ITT - Primary Safety Endpoint
Description
A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.
Time Frame
12 months
Title
Imaging Cohort ITT - Primary Effectiveness Endpoint
Description
Primary Patency within 12 months post-index procedure, which is defined as: Freedom from clinically-driven TLR and Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4. Restenosis determined by either PSVR >2.4 as assessed by an independent DUS core lab or >50% stenosis as assessed by an independent angiographic core lab.
Time Frame
12 months
Title
150mm DEB ITT Cohort - Primary Effectiveness Endpoint
Description
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinical Cohort ITT - MAEs
Description
MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.
Time Frame
12 months
Title
Clinical Cohort ITT - TLR
Description
Any Target lesion revascularisation
Time Frame
12 months
Title
Clinical Cohort ITT - TVR
Description
Any Target vessel revascularisation
Time Frame
12 months.
Title
Clinical Cohort ITT - Device Success
Description
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
Time Frame
Index-procedure
Title
Clinical Cohort ITT - Clinical Success
Description
Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
Time Frame
prior to discharge
Title
Clinical Cohort ITT - MAEs
Description
MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Time Frame
60 months
Title
Clinical Cohort ITT - Clinically-driven TLR
Description
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
60 months
Title
Clinical Cohort ITT - TVR
Time Frame
60 months
Title
Clinical Cohort ITT - TLR
Time Frame
60 months
Title
Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)
Time Frame
60 months
Title
Clinical Cohort ITT - MAEs
Description
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.
Time Frame
30 days
Title
Clinical Cohort ITT - MAEs
Description
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site
Time Frame
6 Months
Title
Clinical Cohort ITT - MAEs
Description
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Time Frame
24 Months
Title
Clinical Cohort ITT - MAEs
Description
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Time Frame
36 Months
Title
Clinical Cohort ITT - MAEs
Description
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Time Frame
48 Months
Title
Clinical Cohort ITT - Clinically-driven TLR
Description
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
30 days
Title
Clinical Cohort ITT - Clinically-driven TLR
Description
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
6 Months
Title
Clinical Cohort ITT - Clinically-driven TLR
Description
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
24 Months
Title
Clinical Cohort ITT - Clinically-driven TLR
Description
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
36 Months
Title
Clinical Cohort ITT - Clinically-driven TLR
Description
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
48 Months
Title
Clinical Cohort ITT - TLR
Description
Any Target lesion revascularisation
Time Frame
6 Months
Title
Clinical Cohort ITT - TLR
Description
Any Target lesion revascularisation
Time Frame
24 Months
Title
Clinical Cohort ITT - TLR
Description
Any Target lesion revascularisation
Time Frame
36 Months
Title
Clinical Cohort ITT - TLR
Description
Any Target lesion revascularisation
Time Frame
48 Months
Title
Clinical Cohort ITT - TVR
Description
Any Target lesion revascularisation
Time Frame
24 Months
Title
Clinical Cohort ITT - TVR
Description
Any Target lesion revascularisation
Time Frame
36 Months
Title
Clinical Cohort ITT - TVR
Description
Any Target lesion revascularisation
Time Frame
48 Months
Title
Clinical Cohort ITT - TVR
Description
Any Target lesion revascularisation
Time Frame
6 Months
Title
Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.
Description
All-cause mortality is reported by using the survival estimate of all cause mortality through 60 months
Time Frame
60 months
Title
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Description
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Time Frame
6 Months
Title
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Description
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Time Frame
12 Months
Title
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Description
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Time Frame
24 Months
Title
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Description
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Time Frame
36 Months
Title
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Description
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
6 Months
Title
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Description
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
12 Months
Title
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Description
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
24 Months
Title
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Description
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
36 Months
Title
Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure
Description
Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9
Time Frame
Post procedure
Title
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Description
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
6 Months
Title
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Description
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
12 Months
Title
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Description
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
24 Months
Title
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Description
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
36 Months
Title
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time Frame
6 Months
Title
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time Frame
12 Months
Title
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time Frame
24 Months
Title
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time Frame
36 Months
Title
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
Description
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time Frame
6 Months
Title
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
Description
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time Frame
12 Months
Title
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
Description
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time Frame
24 Months
Title
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
Description
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time Frame
36 Months
Title
Clinical Cohort ITT - Procedural Success
Description
Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate
Time Frame
at procedure
Title
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion
Time Frame
at 12 months, or at the time of re-intervention
Title
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion
Time Frame
At 12 months, or at the time of re-intervention
Title
150mm DEB ITT Cohort - MAEs
Description
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.
Time Frame
30 days
Title
150mm DEB ITT Cohort - MAEs
Description
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 6 months.
Time Frame
6 months
Title
150mm DEB ITT Cohort - MAEs
Description
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 12 months.
Time Frame
12 months
Title
150mm DEB ITT Cohort - MAEs
Description
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 24 months.
Time Frame
24 months
Title
150mm DEB ITT Cohort - MAEs
Description
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 36 months.
Time Frame
36 months
Title
150mm DEB ITT Cohort - MAEs
Description
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 48 months.
Time Frame
48 months
Title
150mm DEB ITT Cohort - MAEs
Description
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 60 months.
Time Frame
60 months
Title
150mm DEB ITT Cohort - Clinically-driven TLR
Description
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
30 days
Title
150mm DEB ITT Cohort - Clinically-driven TLR
Description
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
6 months
Title
150mm DEB ITT Cohort - Clinically-driven TLR
Description
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
24 months
Title
150mm DEB ITT Cohort - Clinically-driven TLR
Description
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
36 months
Title
150mm DEB ITT Cohort - Clinically-driven TLR
Description
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
48 months
Title
150mm DEB ITT Cohort - Clinically-driven TLR
Description
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
60 months
Title
150mm DEB ITT Cohort - TLR
Description
Any Target lesion revascularisation
Time Frame
6 Months
Title
150mm DEB ITT Cohort - TLR
Description
Any Target lesion revascularisation
Time Frame
12 Months
Title
150mm DEB ITT Cohort - TLR
Description
Any Target lesion revascularisation
Time Frame
24 Months
Title
150mm DEB ITT Cohort - TLR
Description
Any Target lesion revascularisation
Time Frame
36 Months
Title
150mm DEB ITT Cohort - TLR
Description
Any Target lesion revascularisation
Time Frame
48 Months
Title
150mm DEB ITT Cohort - TLR
Description
Any Target lesion revascularisation
Time Frame
60 Months
Title
150mm DEB ITT Cohort - TVR
Description
Any Target lesion revascularisation
Time Frame
6 Months
Title
150mm DEB ITT Cohort - TVR
Description
Any Target lesion revascularisation
Time Frame
12 Months
Title
150mm DEB ITT Cohort - TVR
Description
Any Target lesion revascularisation
Time Frame
24 Months
Title
150mm DEB ITT Cohort - TVR
Description
Any Target lesion revascularisation
Time Frame
36 Months
Title
150mm DEB ITT Cohort - TVR
Description
Any Target lesion revascularisation
Time Frame
48 Months
Title
150mm DEB ITT Cohort - TVR
Description
Any Target lesion revascularisation
Time Frame
60 Months
Title
150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)
Time Frame
60 months
Title
150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure.
Description
All-cause mortality is reported by using the survival estimate of all-cause mortality through 60 months
Time Frame
60 months
Title
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Description
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
6 months.
Title
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Description
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
12 months.
Title
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Description
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
24 months
Title
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Description
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
36 months
Title
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Description
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
6 Months
Title
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Description
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
12 Months
Title
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Description
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
24 Months
Title
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Description
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
36 Months
Title
150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure
Description
Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9
Time Frame
Post procedure
Title
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Description
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
6 Months
Title
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Description
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
12 Months
Title
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Description
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
24 Months
Title
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Description
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time Frame
36 Months
Title
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time Frame
6 Months
Title
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time Frame
12 Months
Title
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time Frame
24 Months
Title
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time Frame
36 Months
Title
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
Description
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time Frame
6 Months
Title
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
Description
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time Frame
12 Months
Title
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
Description
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time Frame
24 Months
Title
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
Description
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time Frame
36 Months
Title
150mm DEB ITT Cohort - Device Success
Description
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
Time Frame
Index-procedure
Title
150mm DEB ITT Cohort - Procedural Success
Description
Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate
Time Frame
at procedure
Title
150mm DEB ITT Cohort - Clinical Success
Description
Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
Time Frame
prior to discharge
Title
Clinical Cohort ITT - All-cause Mortality
Time Frame
30 days
Title
Clinical Cohort ITT - All-cause Mortality
Time Frame
6 Months
Title
Clinical Cohort ITT - All-cause Mortality
Time Frame
12 Months
Title
Clinical Cohort ITT - All-cause Mortality
Time Frame
24 Months
Title
Clinical Cohort ITT - All-cause Mortality
Time Frame
36 Months
Title
Clinical Cohort ITT - All-cause Mortality
Time Frame
48 Months
Title
Clinical Cohort ITT - All-cause Mortality
Description
The difference in death count calculation between the compliance table (participant flow: 253 deaths) and the event table (244 deaths) is explained as follow: Calendar days (365/year) is used for compliance table whereas 360-day annual cutoff is used for event rate calculation Compliance table used visit window as specified by protocol (60 days for 5-year follow-up) whereas, not window is used for event rate calculation Nine patients died between 1801 and 1885 (1825 + 60) and were therefore not included in the 5-year death rate summary but were included in the compliance summary for patients that died through the upper window of the 60 month visit. The denominator of 1215 for 1800-day event rate includes those who had an event within 1800 days and those who did not have any event but had at least 1740 days of follow-up (1740 is the low bound of the 60-day visit window from the target day of 1800)
Time Frame
60 Months
Title
Clinical Cohort ITT - Clinically-driven TVR
Description
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
30 days
Title
Clinical Cohort ITT - Clinically-driven TVR
Description
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
6 Months
Title
Clinical Cohort ITT - Clinically-driven TVR
Description
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
12 Months
Title
Clinical Clinical Cohort ITT - Clinically-driven TVR
Description
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
24 Months
Title
Clinical Cohort ITT - Clinically-driven TVR
Description
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
36 Months
Title
Clinical Cohort ITT - Clinically-driven TVR
Description
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
48 Months
Title
Clinical Cohort ITT - Clinically-driven TVR
Description
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
60 Months
Title
Clinical Cohort ITT - Major Target Limb Amputation
Time Frame
30 days
Title
Clinical Cohort ITT - Major Target Limb Amputation
Time Frame
6 Months
Title
Clinical Cohort ITT - Major Target Limb Amputation
Time Frame
12 Months
Title
Clinical Cohort ITT - Major Target Limb Amputation
Time Frame
24 Months
Title
Clinical Cohort ITT - Major Target Limb Amputation
Time Frame
36 Months
Title
Clinical Cohort ITT - Major Target Limb Amputation
Time Frame
48 Months
Title
Clinical Cohort ITT - Major Target Limb Amputation
Time Frame
60 Months
Title
150mm DEB ITT Cohort - All-cause Mortality
Time Frame
30 days
Title
150mm DEB ITT Cohort - All-cause Mortality
Time Frame
6 Months
Title
150mm DEB ITT Cohort - All-cause Mortality
Time Frame
12 Months
Title
150mm DEB ITT Cohort - All-cause Mortality
Time Frame
24 Months
Title
150mm DEB ITT Cohort - All-cause Mortality
Time Frame
36 Months
Title
150mm DEB ITT Cohort - All-cause Mortality
Time Frame
48 Months
Title
150mm DEB ITT Cohort - All-cause Mortality
Time Frame
60 Months
Title
150mm DEB ITT Cohort - Clinically-driven TVR
Description
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
30 days
Title
150mm DEB ITT Cohort - Clinically-driven TVR
Description
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
6 Months
Title
150mm DEB ITT Cohort - Clinically-driven TVR
Description
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
12 Months
Title
150mm DEB ITT Cohort - Clinically-driven TVR
Description
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
24 Months
Title
150mm DEB ITT Cohort - Clinically-driven TVR
Description
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
36 Months
Title
150mm DEB ITT Cohort - Clinically-driven TVR
Description
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
48 Months
Title
150mm DEB ITT Cohort - Clinically-driven TVR
Description
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.
Time Frame
60 Months
Title
150mm DEB ITT Cohort - Major Target Limb Amputation
Time Frame
30 days
Title
150mm DEB ITT Cohort - Major Target Limb Amputation
Time Frame
6 Months
Title
150mm DEB ITT Cohort - Major Target Limb Amputation
Time Frame
12 Months
Title
150mm DEB ITT Cohort - Major Target Limb Amputation
Time Frame
24 Months
Title
150mm DEB ITT Cohort - Major Target Limb Amputation
Time Frame
36 Months
Title
150mm DEB ITT Cohort - Major Target Limb Amputation
Time Frame
48 Months
Title
150mm DEB ITT Cohort - Major Target Limb Amputation
Time Frame
60 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General inclusion Criteria: Age ≥ 18 years or minimum age as required by local regulations. Subject with documented diagnosis of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and/or popliteal artery (PA) (including P1, P2, P3) classified as Rutherford class 2-3-4. Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days. General exclusion Criteria: High probability of non-adherence to Clinical Investigation Protocol follow-up requirements. Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations). Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Tepe, MD
Organizational Affiliation
Klinikum Rosenheim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary Ansel, MD
Organizational Affiliation
MidOhio Cardiology and Vascular Consultants
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Bosiers, MD
Organizational Affiliation
AZ Sint Blasius
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Do-Dai Do, MD
Organizational Affiliation
Swiss Cardiovascular Center, Inselspital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Gaines, MD
Organizational Affiliation
Sheffield Vascular Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alvaro Razuk, MD
Organizational Affiliation
Faculdade de Ciências Médicas da Santa Casa de Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundación Favaloro
City
Buenos Aires
Country
Argentina
Facility Name
Clinica La Sagrada Familia
City
Bueos Aires
Country
Argentina
Facility Name
Royal Prince Alfred Hospital
City
Sydney
ZIP/Postal Code
NSW 2050
Country
Australia
Facility Name
Medizinische Universität Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Landesklinikum Thermenregion Mödling
City
Mödling
ZIP/Postal Code
2340
Country
Austria
Facility Name
Onze-Lieve-Vrouwziekenuis
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Imelda Ziekenhuis
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ St. Blasius
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Ziekenhuis Oost Limburg - Campus St.-Jan
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Regionaal Ziekenhuis Heilig Hart
City
Tienen
ZIP/Postal Code
3300
Country
Belgium
Facility Name
Centre hospitalier universitaire Sherbrooke (CHUS)
City
Sherbrooke
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
Country
Canada
Facility Name
Clinica Santa Maria
City
Medellin
Country
Colombia
Facility Name
Clinica Medilaser Neiva
City
Neiva
Country
Colombia
Facility Name
Faculty Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
As-Salam International Hospital
City
Cairo
Country
Egypt
Facility Name
Egypt Air Hospital
City
Cairo
Country
Egypt
Facility Name
Helsingin Seudun Yliopistollinen Keskussairaala
City
Helsinki
Country
Finland
Facility Name
Group Hospitalier Pellegrin - CHU
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Les Hospitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Herzzentrum Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Augusta-Krankenhaus
City
Duesseldorf
Country
Germany
Facility Name
Augusta Krankenhaus
City
Düsseldorf
ZIP/Postal Code
40472
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitatsklinikum Leipzig AoR
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Park-Krankenhaus Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
St. Franziskus Hospital GmbH
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
RoMed Klinikum Rosenheim
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
University Hospital of Patras
City
Patra
ZIP/Postal Code
TK26504
Country
Greece
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Bacs Kiskun Megyei Korhaz
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Carmel Medical Centre
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Rabin Medical Center - Beilison Hospital
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Policlinico Vittorio Emanuele
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Maria Eleonora Hospital
City
Palermo
ZIP/Postal Code
90135
Country
Italy
Facility Name
Policlinico Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Severence Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
443-380
Country
Korea, Republic of
Facility Name
Kaunas Mecial University Clinic
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Jeroen Bosch Ziekenhuis
City
's Hertogenbosch
ZIP/Postal Code
5223GZ
Country
Netherlands
Facility Name
Rijnstate Ziekenhuis
City
Arnhem
ZIP/Postal Code
6800TA
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623EJ
Country
Netherlands
Facility Name
Sint Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3430EM
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Facility Name
Euromedic Medical Center
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 2
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Hospital Santa Marta
City
Lisbon
ZIP/Postal Code
1169-024
Country
Portugal
Facility Name
City Clinical Hospital named after M.E. Zhadkevich
City
Moscow
ZIP/Postal Code
121374
Country
Russian Federation
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH)
City
Banská Bystrica
ZIP/Postal Code
97401
Country
Slovakia
Facility Name
Národný ústav srdcových a cievnych chorôb a.s. (NUSCH)
City
Bratislava
ZIP/Postal Code
83348
Country
Slovakia
Facility Name
Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH)
City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Facility Name
University Medical Centre Maribor
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Facility Name
Karolinska Universitetssjukhuset
City
Solna
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Inselspital - Universitätsspial Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Hopital Cantonal HFR
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
Kantonspital Luzern
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M139WL
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S57AU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36137674
Citation
Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043.
Results Reference
derived
PubMed Identifier
35864209
Citation
Brodmann M, Lansink W, Guetl K, Micari A, Menk J, Zeller T. Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1276-1287. doi: 10.1007/s00270-022-03214-y. Epub 2022 Jul 21.
Results Reference
derived
PubMed Identifier
35635160
Citation
Zeller T, Brodmann M, Ansel GM, Scheinert D, Choi D, Tepe G, Menk J, Micari A. Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study. EuroIntervention. 2022 Dec 2;18(11):e940-e948. doi: 10.4244/EIJ-D-21-01098.
Results Reference
derived
PubMed Identifier
32583749
Citation
Torsello G, Stavroulakis K, Brodmann M, Micari A, Tepe G, Veroux P, Benko A, Choi D, Vermassen FEG, Jaff MR, Guo J, Dobranszki R, Zeller T; IN.PACT Global Investigators. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort. J Endovasc Ther. 2020 Oct;27(5):693-705. doi: 10.1177/1526602820931477. Epub 2020 Jun 25.
Results Reference
derived
PubMed Identifier
31543165
Citation
Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieche C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030.
Results Reference
derived
PubMed Identifier
30931726
Citation
Reijnen MMPJ, van Wijck I, Zeller T, Micari A, Veroux P, Keirse K, Lee SW, Li P, Voulgaraki D, Holewijn S. Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study. J Endovasc Ther. 2019 Jun;26(3):305-315. doi: 10.1177/1526602819839044. Epub 2019 Apr 1.
Results Reference
derived
PubMed Identifier
30846089
Citation
Tepe G, Micari A, Keirse K, Zeller T, Scheinert D, Li P, Schmahl R, Jaff MR; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):484-493. doi: 10.1016/j.jcin.2018.12.004.
Results Reference
derived
PubMed Identifier
30690141
Citation
Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25. Erratum In: J Am Coll Cardiol. 2019 Feb 28;:
Results Reference
derived
PubMed Identifier
30630355
Citation
Zeller T, Brodmann M, Micari A, Keirse K, Peeters P, Tepe G, Scheinert D, Jaff MR, Rocha-Singh KJ, Li P, Schmahl R, Ansel GM; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain. Circ Cardiovasc Interv. 2019 Jan;12(1):e007730. doi: 10.1161/CIRCINTERVENTIONS.118.007730. No abstract available.
Results Reference
derived
PubMed Identifier
30354645
Citation
Banerjee S, Khalili H. Drug-Coated Balloon for Long Femoropopliteal Lesions. Circ Cardiovasc Interv. 2018 Oct;11(10):e007084. doi: 10.1161/CIRCINTERVENTIONS.118.007084. No abstract available.
Results Reference
derived
PubMed Identifier
30354636
Citation
Scheinert D, Micari A, Brodmann M, Tepe G, Peeters P, Jaff MR, Wang H, Schmahl R, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease. Circ Cardiovasc Interv. 2018 Oct;11(10):e005654. doi: 10.1161/CIRCINTERVENTIONS.117.005654.
Results Reference
derived
PubMed Identifier
30280648
Citation
Ansel GM, Brodmann M, Keirse K, Micari A, Jaff MR, Rocha-Singh K, Fernandez EJ, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study. J Endovasc Ther. 2018 Dec;25(6):673-682. doi: 10.1177/1526602818803119. Epub 2018 Oct 3.
Results Reference
derived
PubMed Identifier
29798770
Citation
Micari A, Brodmann M, Keirse K, Peeters P, Tepe G, Frost M, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study. JACC Cardiovasc Interv. 2018 May 28;11(10):945-953. doi: 10.1016/j.jcin.2018.02.019.
Results Reference
derived

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IN.PACT Global Clinical Study

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