Back to resultsA Study Evaluating the Endovascular Treatment of Subjects With Stenotic or Restenotic Lesions of the Common Femoral Artery With the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy (SUPERSURG-RCT)
Primary Purpose
Peripheral Arterial Disease
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Supera Peripheral Stent System treatment group
Endarterectomy treatment group
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
- Patient is ≥18 years old
- Patient presenting a score from 2 to 4 following Rutherford classification
- Patient is willing to comply with specified follow-up evaluations at the specified times
- Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- Patient has a life expectancy of at least 12 months
- Prior to enrolment, the guidewire has crossed the target lesion in the endovascular arm. In the surgical arm, the endarterectomy needs to be performed with primary suture or patch implantation
- De novo stenotic or restenotic (post-PTA) lesions (<100%) located in the common femoral artery, suitable for both endovascular therapy and endarterectomy
- Target lesion is located within the native CFA: localized between 1cm proximal to the origin of the circumflex iliac artery and the proximal (2cm) superficial femoral artery and deep femoral artery (2cm) (Azéma type 2 and 3 lesions)
- There is angiographic evidence of a patent deep femoral artery and/or superficial femoral artery
- The target lesion has angiographic evidence of >50% stenosis. Occlusions are not allowed.
Exclusion Criteria:
- Presence of another stent in the target vessel that was placed during a previous procedure
- Previous open surgery in the ipsilateral groin
- Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
- Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
- Patients with known hypersensitivity to nickel-titanium and heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
- Known allergy to contrast media that cannot be adequately pre-medicated prior to study procedure
- Patients with uncorrected bleeding disorders
- Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
- Ipsilateral inflow (aorto-iliac) artery treatment before target lesion treatment with a residual stenosis >30%
- Use of thrombectomy, atherectomy or laser device during procedure
- Any patient considered to be hemodynamically unstable at onset of procedure
- Severe medical comorbidities (untreated coronary artery disease/congestive heart failure, severe chronic obstructive pulmonary disease, metastatic malignancy, dementia, etc.) or other medical condition that would prelude compliance with the study protocol or 1-year life expectancy
- Major distal amputation (above the ankle) in the study limb or non-study limb
- Target lesion involves an (pseudo-)aneurysm or is adjacent to an (pseudo-)aneurysm (within 5mm)
- Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤30% residual diameter stenosis without death or major complications
- Presence of an aortic, iliac or femoral artificial graft
- Occlusion in the target lesion
- Presence of an interposition graft with/without profunda reimplantation
Sites / Locations
- O.L.V. HospitalRecruiting
- Imelda HospitalRecruiting
- A.Z. Sint-BlasiusRecruiting
- Z.O.L.Recruiting
- Az GroeningeRecruiting
- AZ Sint-Maarten
- A.Z. Jan PortaelsRecruiting
- Maastricht UMC+Recruiting
- Dijklander hospitalRecruiting
- Noordwest ziekenhuisgroepRecruiting
- St Antonius HospitalRecruiting
- Bonifraterskie Centrum MedyczneRecruiting
- Karol Marcinkowski Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Supera Peripheral Stent System treatment group
Endarterectomy treatment group
Arm Description
These patients will be treated endovascularly with the Supera Peripheral Stent System (Abbott).
These patients will be treated surgically with endarterectomy
Outcomes
Primary Outcome Measures
Primary efficacy endpoint at 12 months: Primary patency
To demonstrate the non-inferior efficacy in the group treated with the Supera stent compared to the group treated with endarterectomy for the treatment of atherosclerosis in the common femoral artery (CFA). Efficacy is defined as primary patency: freedom from restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis as assessed by an independent DUS core lab in CFA without a previous target lesion revascularization through 12 months post-index procedure.
Primary safety endpoint at 30 days post-index procedure
To demonstrate superior safety in the group treated with the Supera stent compared to the endarterectomy group for the treatment of atherosclerosis in the CFA. Safety is defined as a composite of overall death, cardiac, pulmonary, renal complications, sepsis, target lesion revascularization (TLR) and wound-related complications (haematoma, seroma, lymphocele, lymphatic leaks with lymphatic fistula, surgical site infections (SSIs) (Szilagyi grade I, II and III)).
Secondary Outcome Measures
Technical success: post-procedure residual stenosis <30%
Supera group: Defined as the ability to cross and stent the lesion to achieve residual angiographic stenosis no greater than 30%.
Endarterectomy group: defined as the ability to remove the atherosclerotic plaque with or without patch (interposition grafts are not allowed). In the imaging subcohort the endarterectomy is considered successful when a residual stenosis no greater than 30% per visual estimation is confirmed.
Primary patency in the deep femoral artery (DFA), post-index procedure and at 6-, 12-, 24- and 36-months post-index procedure
Primary patency in the DFA is defined as freedom from an occlusion in the DFA as assessed by PSV-values. This PSV-value will be assessed pre-procedure, post-procedure, 6 months and 12 months post-index procedure. At 12 months, the PSV-value will be core-lab controlled.
Primary patency at 6, 24 and 36 months
Primary patency is a composite of freedom from clinically-driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis as assessed by DUS in CFA) through 6 months post-index procedure
TLR at 6-, 12-, 24- and 36-months post-index procedure
TLR is defined as a reintervention to maintain or restore the patency in the target lesion. TLR is clinically-driven (CD) when the TLR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure
TVR at 6-, 12-, 24- and 36-months post-index procedure
Target vessel revascularization (TVR) is defined as a reintervention to maintain or restore the patency in the target vessel. TVR is clinically-driven (CD) when the TVR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure
Binary restenosis at 6, 12, 24 and 36 months
Binary restenosis is defined as restenosis confirmed by DUS PSVR ≥2.4 or ≥50% stenosis as assessed by angiographic and DUS images. At 12 months, the images will be core lab controlled
Duration of initial hospitalisation stay
Number of hours/days of the initial hospitalisation stay.
Sustained clinical improvement at 6-, 12-, 24- and 36-months post-index procedure
Clinical improvement is defined as freedom from major target limb amputation, TVR, worsening target limb Rutherford class (compared to baseline) and decrease in target limb ankle brachial index (ABI) or toe brachial index (TBI) ≥0.15 (compared to baseline)
Change in Walking Impairment Questionnaire (WIQ) score from baseline to 6, 12, 24 and 36 months
change in walking impairment questionnaire (WIQ) score from baseline to 6 and 12 months.
The WIQ consists of 6 sections each consisting of multiple questions. Each question is scored from 0 to 4 (0 meaning a lot of problems and 4 no problems at all). The scores per section are summed up and recalculated to percentages (100% meaning very good and 0% meaning very bad). All the sections are averaged to give the final WIQ-score.
Change in target limb Rutherford class from baseline to 6, 12, 24 and 36 months
Change in target limb Rutherford class from baseline to 6, 12, 24 and 36 months
Change in target limb resting ABI or TBI from baseline to 6, 12, 24 and 36 months
Change in target limb resting ABI or TBI from baseline to 6, 12, 24 and 36 months
All cause death at 6, 12, 24 and 36 months
All cause death at 6, 12, 24 and 36 months
Thrombosis at the target lesion at 6, 12, 24 and 36 months
Thrombosis at the target lesion at 6, 12, 24 and 36 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04349657
Brief Title
A Study Evaluating the Endovascular Treatment of Subjects With Stenotic or Restenotic Lesions of the Common Femoral Artery With the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy
Acronym
SUPERSURG-RCT
Official Title
An RCT Evaluating the Safety and Efficacy of the Endovascular Treatment of Subjects With Stenotic or Restenotic Lesions of the Common Femoral Artery With the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ID3 Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The SUPERSURG RCT trial investigates the efficacy and safety of the endovascular treatment of stenosis or restenosis in the common femoral artery (CFA) of patients presenting with Rutherford classification 2,3 or 4 with a Supera Vascular Mimetic Implant of Abbott, compared to classic surgical common femoral artery endarterectomy. The Supera Vascular Mimetic Implant has an interwoven design and has a high crush resistance and is, when correctly implanted, an ideal stent to treat eccentric calcified plaques in the CFA.
An expected total of 143 patients will be treated with the Vascular Mimetic Implant of Abbott and compared to a control group of another 143 patients that will be treated with classic surgical endarterectomy of the common femoral artery. Assignment to the treatment groups will be at random.
Patients will be invited for a follow-up visit at 1, 6, 12, 24 and 36 months post-procedure.
The primary efficacy endpoint is defined as follows: freedom from clinically-driven target lesion revascularization and binary restenosis at 12 months. The primary safety endpoint is defined as follows: a composite of overall death, cardiac, pulmonary, renal complications, sepsis, target lesion revascularisation and wound related complications through 30 days post-index procedure.
The secondary endpoints are defined as technical success, primary patency in the deep femoral artery, primary patency in the target lesion, target lesion revascularisation, target vessel revascularisation, binary restenosis, duration of initial hospital stay, sustained clinical improvement, change of walking impairment questionnaire score from baseline, change in target limb Rutherford classification, change in target limb ABI/TBI from baseline, all cause death, thrombosis at the target lesion through 6, 12, 24 and 36 months post-procedure.
Detailed Description
The objective of this clinical investigation is to assess the safety and efficacy of the Supera Vascular Mimetic Implant for the treatment of stenotic or restenotic lesions of the common femoral artery. Furthermore, a non-inferiority hypothesis in terms of efficacy and a superiority in terms of safety will be tested with the endovascular treatment with Supera compared to surgical endarterectomy of the common femoral artery.
The patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should be geographically stable, willing and able to cooperate in this clinical study, and remain available for long term follow-up. The patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion.
Prior to the index procedure the following will be collected: an informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of acute limb ischemia (Rutherford category), the resting ankle-brachial index (ABI) or toe-brachial index (TBI), blood sample test (complete blood count, comprehensive metabolic panel and if applicable pregnancy test) and a walking impairment questionnaire. Randomization will also occur prior to the procedure.
During the procedure patients that are randomized within the endarterectomy group will be treated according to the institutions standard of care. For patients that are randomized within the Supera arm, the guidewire will cross the entire study lesion after which the lesion will be assessed through angiography. Pre-dilatation of the target lesion with an uncoated PTA-balloon is mandatory and will be followed by stenting with the Supera stent according to the instructions for use. Postdilatation of the stent is allowed but not mandatory.
The regular follow-up is necessary to monitor the condition of the patient and the results of the procedure. The patients will be invited for the following required follow-up visits at 1, 6, 12, 24 and 36 months. During these visit the following data will be collected: medication record, physical exam, target limb ABI/TBI and Rutherford classification, duplex ultrasound of target vessel, walking impairment questionnaire and possible adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The subjects will be randomly assigned in a 1:1 manner to treatment with either the Supera stent or endarterectomy.
Masking
None (Open Label)
Masking Description
All parties will know in what arm the study subject is randomized before the study procedure
Allocation
Randomized
Enrollment
286 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supera Peripheral Stent System treatment group
Arm Type
Experimental
Arm Description
These patients will be treated endovascularly with the Supera Peripheral Stent System (Abbott).
Arm Title
Endarterectomy treatment group
Arm Type
Active Comparator
Arm Description
These patients will be treated surgically with endarterectomy
Intervention Type
Device
Intervention Name(s)
Supera Peripheral Stent System treatment group
Intervention Description
Percutaneous endovascular stenting with the Supera Peripheral Stent System
Intervention Type
Procedure
Intervention Name(s)
Endarterectomy treatment group
Intervention Description
Surgical treatment through endarterectomy
Primary Outcome Measure Information:
Title
Primary efficacy endpoint at 12 months: Primary patency
Description
To demonstrate the non-inferior efficacy in the group treated with the Supera stent compared to the group treated with endarterectomy for the treatment of atherosclerosis in the common femoral artery (CFA). Efficacy is defined as primary patency: freedom from restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis as assessed by an independent DUS core lab in CFA without a previous target lesion revascularization through 12 months post-index procedure.
Time Frame
12 months post-index-procedure
Title
Primary safety endpoint at 30 days post-index procedure
Description
To demonstrate superior safety in the group treated with the Supera stent compared to the endarterectomy group for the treatment of atherosclerosis in the CFA. Safety is defined as a composite of overall death, cardiac, pulmonary, renal complications, sepsis, target lesion revascularization (TLR) and wound-related complications (haematoma, seroma, lymphocele, lymphatic leaks with lymphatic fistula, surgical site infections (SSIs) (Szilagyi grade I, II and III)).
Time Frame
30 days post-index-procedure
Secondary Outcome Measure Information:
Title
Technical success: post-procedure residual stenosis <30%
Description
Supera group: Defined as the ability to cross and stent the lesion to achieve residual angiographic stenosis no greater than 30%.
Endarterectomy group: defined as the ability to remove the atherosclerotic plaque with or without patch (interposition grafts are not allowed). In the imaging subcohort the endarterectomy is considered successful when a residual stenosis no greater than 30% per visual estimation is confirmed.
Time Frame
Index procedure
Title
Primary patency in the deep femoral artery (DFA), post-index procedure and at 6-, 12-, 24- and 36-months post-index procedure
Description
Primary patency in the DFA is defined as freedom from an occlusion in the DFA as assessed by PSV-values. This PSV-value will be assessed pre-procedure, post-procedure, 6 months and 12 months post-index procedure. At 12 months, the PSV-value will be core-lab controlled.
Time Frame
6, 12, 24 and 36 months post-index-procedure
Title
Primary patency at 6, 24 and 36 months
Description
Primary patency is a composite of freedom from clinically-driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis as assessed by DUS in CFA) through 6 months post-index procedure
Time Frame
6, 24 and 36 months post-index-procedure
Title
TLR at 6-, 12-, 24- and 36-months post-index procedure
Description
TLR is defined as a reintervention to maintain or restore the patency in the target lesion. TLR is clinically-driven (CD) when the TLR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure
Time Frame
6, 12, 24 and 36 months post-index-procedure
Title
TVR at 6-, 12-, 24- and 36-months post-index procedure
Description
Target vessel revascularization (TVR) is defined as a reintervention to maintain or restore the patency in the target vessel. TVR is clinically-driven (CD) when the TVR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure
Time Frame
6, 12, 24 and 36 months post-index-procedure
Title
Binary restenosis at 6, 12, 24 and 36 months
Description
Binary restenosis is defined as restenosis confirmed by DUS PSVR ≥2.4 or ≥50% stenosis as assessed by angiographic and DUS images. At 12 months, the images will be core lab controlled
Time Frame
6, 12, 24 and 36 months post-index-procedure
Title
Duration of initial hospitalisation stay
Description
Number of hours/days of the initial hospitalisation stay.
Time Frame
Up to 4 weeks
Title
Sustained clinical improvement at 6-, 12-, 24- and 36-months post-index procedure
Description
Clinical improvement is defined as freedom from major target limb amputation, TVR, worsening target limb Rutherford class (compared to baseline) and decrease in target limb ankle brachial index (ABI) or toe brachial index (TBI) ≥0.15 (compared to baseline)
Time Frame
6, 12, 24 and 36 months post-index-procedure
Title
Change in Walking Impairment Questionnaire (WIQ) score from baseline to 6, 12, 24 and 36 months
Description
change in walking impairment questionnaire (WIQ) score from baseline to 6 and 12 months.
The WIQ consists of 6 sections each consisting of multiple questions. Each question is scored from 0 to 4 (0 meaning a lot of problems and 4 no problems at all). The scores per section are summed up and recalculated to percentages (100% meaning very good and 0% meaning very bad). All the sections are averaged to give the final WIQ-score.
Time Frame
6, 12, 24 and 36 months post-index-procedure
Title
Change in target limb Rutherford class from baseline to 6, 12, 24 and 36 months
Description
Change in target limb Rutherford class from baseline to 6, 12, 24 and 36 months
Time Frame
6, 12, 24 and 36 months post-index-procedure
Title
Change in target limb resting ABI or TBI from baseline to 6, 12, 24 and 36 months
Description
Change in target limb resting ABI or TBI from baseline to 6, 12, 24 and 36 months
Time Frame
6, 12, 24 and 36 months post-index-procedure
Title
All cause death at 6, 12, 24 and 36 months
Description
All cause death at 6, 12, 24 and 36 months
Time Frame
6, 12, 24 and 36 months post-index-procedure
Title
Thrombosis at the target lesion at 6, 12, 24 and 36 months
Description
Thrombosis at the target lesion at 6, 12, 24 and 36 months
Time Frame
6, 12, 24 and 36 months post-index-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is ≥18 years old
Patient presenting a score from 2 to 4 following Rutherford classification
Patient is willing to comply with specified follow-up evaluations at the specified times
Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
Patient has a life expectancy of at least 12 months
Prior to enrolment, the guidewire has crossed the target lesion in the endovascular arm. In the surgical arm, the endarterectomy needs to be performed with primary suture or patch implantation
De novo stenotic or restenotic (post-PTA) lesions (<100%) located in the common femoral artery, suitable for both endovascular therapy and endarterectomy
Target lesion is located within the native CFA: localized between 1cm proximal to the origin of the circumflex iliac artery and the proximal (2cm) superficial femoral artery and deep femoral artery (2cm) (Azéma type 2 and 3 lesions)
There is angiographic evidence of a patent deep femoral artery and/or superficial femoral artery
The target lesion has angiographic evidence of >50% stenosis. Occlusions are not allowed.
Exclusion Criteria:
Presence of another stent in the target vessel that was placed during a previous procedure
Previous open surgery in the ipsilateral groin
Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
Patients with known hypersensitivity to nickel-titanium and heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
Known allergy to contrast media that cannot be adequately pre-medicated prior to study procedure
Patients with uncorrected bleeding disorders
Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
Ipsilateral inflow (aorto-iliac) artery treatment before target lesion treatment with a residual stenosis >30%
Use of thrombectomy, atherectomy or laser device during procedure
Any patient considered to be hemodynamically unstable at onset of procedure
Severe medical comorbidities (untreated coronary artery disease/congestive heart failure, severe chronic obstructive pulmonary disease, metastatic malignancy, dementia, etc.) or other medical condition that would prelude compliance with the study protocol or 1-year life expectancy
Major distal amputation (above the ankle) in the study limb or non-study limb
Target lesion involves an (pseudo-)aneurysm or is adjacent to an (pseudo-)aneurysm (within 5mm)
Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤30% residual diameter stenosis without death or major complications
Presence of an aortic, iliac or femoral artificial graft
Occlusion in the target lesion
Presence of an interposition graft with/without profunda reimplantation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofie Vercauteren, MSc
Phone
+32 (0)52 25 27 45
Ext
+32
Email
office@id3medical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koen Deloose, MD
Organizational Affiliation
A.Z. Sint-Blasius
Official's Role
Principal Investigator
Facility Information:
Facility Name
O.L.V. Hospital
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lieven Maene, MD
First Name & Middle Initial & Last Name & Degree
Lieven Maene, MD
First Name & Middle Initial & Last Name & Degree
Roel Beelen, MD
Facility Name
Imelda Hospital
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jürgen Verbist, MD
First Name & Middle Initial & Last Name & Degree
Jürgen Verbist, MD
First Name & Middle Initial & Last Name & Degree
Wouter Van den Eynde, MD
Facility Name
A.Z. Sint-Blasius
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koen Deloose, MD
First Name & Middle Initial & Last Name & Degree
Koen Deloose, MD
First Name & Middle Initial & Last Name & Degree
Joren Callaert, MD
Facility Name
Z.O.L.
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wouter Lansink, MD
First Name & Middle Initial & Last Name & Degree
Wouter Lansink, MD
Facility Name
Az Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Lerut, MD
First Name & Middle Initial & Last Name & Degree
Philip Lerut, MD
First Name & Middle Initial & Last Name & Degree
Paul Wallaert, MD
Facility Name
AZ Sint-Maarten
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves Tielemans, MD
First Name & Middle Initial & Last Name & Degree
Yves Tielemans, MD
First Name & Middle Initial & Last Name & Degree
Catherine Terry, MD
Facility Name
A.Z. Jan Portaels
City
Vilvoorde
ZIP/Postal Code
1800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorn Robijn, MD
First Name & Middle Initial & Last Name & Degree
Jorn Robijn, MD
First Name & Middle Initial & Last Name & Degree
Kim Taeymans, MD
Facility Name
Maastricht UMC+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barend Mees, MD
Phone
+31(0)43-3877478
Email
barend.mees@mumc.nl
Facility Name
Dijklander hospital
City
Hoorn
State/Province
Noord-Holland
ZIP/Postal Code
1624
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Tournoij, MD
Phone
0299-457644
Email
etournoij@wlz.nl
First Name & Middle Initial & Last Name & Degree
Arno Wiersema, MD
Email
arno@wiersema.nu
Facility Name
Noordwest ziekenhuisgroep
City
Alkmaar
ZIP/Postal Code
1815
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel van den Heuvel
First Name & Middle Initial & Last Name & Degree
Daniel van den Heuvel
Facility Name
St Antonius Hospital
City
Utrecht
ZIP/Postal Code
3543
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel van den Heuvel, MD
Phone
+31 88 320 80 63
Email
d.van.den.heuvel@antoniusziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
Olaf Bakker, MD
Email
o.bakker@antoniusziekenhuis.nl
Facility Name
Bonifraterskie Centrum Medyczne
City
Kraków
ZIP/Postal Code
31-061
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maciej Chwala
First Name & Middle Initial & Last Name & Degree
Maciej Chwala
Facility Name
Karol Marcinkowski Medical University
City
Poznań
ZIP/Postal Code
61-848
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jolanta Tomczak
First Name & Middle Initial & Last Name & Degree
Zbigniew Krasiński, Prof
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating the Endovascular Treatment of Subjects With Stenotic or Restenotic Lesions of the Common Femoral Artery With the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy
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