The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring Atherosclerosis, Superficial Femoral Artery, Proximal Popliteal Artery
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years and ≤ 85 years.
- Subject with documented diagnosis of peripheral arterial disease (PAD) classified as Rutherford class 2-3-4 in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) above the knee, located in the arterial segment starting at least 1 cm beyond the Common femoral artery (CFA) bifurcation between the superficial and profunda femoris arteries (proximal anatomical landmark to the distal P1 segment of the popliteal artery at the level of the proximal edge of the patella (distal anatomical landmark).
- Target lesion consists of a single de novo or non-stented restenotic lesion (or a tandem lesion) or is a combination lesion
- Reference vessel diameter ≥ 4 mm and ≤ 7 mm by visual estimate.
- Subject able to walk without assistive devices (e.g. walker, cane).
- If subject has ipsilateral/contralateral iliac disease that requires treatment during the index procedure
- Angiographic evidence of adequate distal run-off to the foot (at least one native calf vessel [posterior tibial, anterior tibial, or peroneal arteries] is patent, defined as < 50% diameter stenosis).
- Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before index procedure and willing to use a reliable method of birth control for the duration of the study or must have documented adequate birth control.
- Signed and dated Patient Informed Consent (PIC) form.
- Understands and accepts the duration of the study and is able and willing to comply with all requirements, including follow-up visits and evaluations.
- Life expectancy, in the Investigator's opinion, of at least 12 months.
Exclusion Criteria:
- In the investigator's opinion subject is unlikely to comply with the followup schedule.
- Stroke or STEMI within the 3 months prior to index procedure.
- Either local or systemic thrombolytic therapy within 48 hours prior to the index procedure.
- Inability to tolerate oral anticoagulation therapy (blood thinners such as warfarin) while on concomitant dual antiplatelet therapy (DAPT).
- Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
- Breastfeeding woman.
- Chronic renal insufficiency with serum creatinine > 2.5 mg/dL within 14 days prior to index procedure.
- WBC < 3.0 (3,000 cells/mm3) within 14 days prior to index procedure.
- PLT count < 80,000 cells/mm3 or > 700,000 cells/mm3 within 14 days prior to index procedure.
- Known or suspected active systemic infection evidenced by WBC > 14.0 (14000/mm3) within 14 days prior to index procedure.
- Diagnosed with bleeding diatheses or hypercoagulable state.
- Subject is enrolled in another investigational device, drug or biologic study or subject was previously enrolled to the IN.PACT SFA China trial.
- Any major (e.g., cardiac. peripheral, abdominal) surgical procedure or intervention performed within 30 days prior to the index procedure.
- Any major (e.g., cardiac. peripheral, abdominal) elective procedure or intervention within 30 days post index procedure.
- Contralateral SFA/PPA disease requiring treatment in the same setting as index procedure.
- Presence of additional lesions in the target vessel that require treatment during index procedure but do not meet the definitions of tandem lesions.
- Target lesion is an in-stent or post-DEB restenosis or has been previously treated with bypass surgery.
- Failure to successfully cross the target lesion with a guide wire
- Lesion within or adjacent to an aneurysm.
- Acute or sub-acute thrombus in the target vessel.
- Angiographic evidence of severe calcification
- Target lesion known in advance of enrollment to require treatment with alternative therapy such as drug-eluting stent (DES), drug-eluting balloon (DEB), laser, atherectomy, cryoplasty, re-entry devices, cutting/scoring balloon, brachytherapy. Use of embolic protection devices is also prohibited.
- Pre-dilation resulted in a major ( ≥ Grade D) flow-limiting dissection (observed on 2 orthogonal views) or residual stenosis > 70% and translesional peak gradient > 10mm Hg.
Sites / Locations
- 301 Hospital/Chinese PLA General Hospital
- Anzhen Hospital, Capital Medical University
- Peking University First Hospital
- Xuanwu Hospital, Capital Medical University
- West China Hospital
- The First Affiliated Hospital of Chongqing Medical University
- The First Affiliated Hospital, Dalian Medical University
- The First Affiliated Hospital of Fujian Medical University
- The 1stAffiliated Hospital of Sun Yat-sen University
- The 2nd Affiliated Hospital of Harbin Medical University
- The first affiliated Hospital of Harbin Medical University
- Nanjing Drum Tower Hospital
- Shanghai 9th People Hospital Affiliated Shanghai Jiao Tong University School of Medecine
- Zhongshan Hospital, Fudan University
- Shengjing Hospital of China Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IN.PACT Admiral
Arm Description
Outcomes
Primary Outcome Measures
Primary effectiveness endpoint: Primary patency within 12 months post-index procedure
Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR)1 and freedom from restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.4
Primary Safety Endpoint
A composite of freedom from device- and procedure-related mortality, freedom from major target limb amputation and freedom from clinicallydriven TLR within 30-day post-index procedure
Secondary Outcome Measures
Major Adverse Events
MAE is defined as all-cause mortality, clinically-driven Target Vessel Revascularization (TVR), major target limb amputation or thrombosis at the target lesion site, through 12 months
Death of any cause
Death of any cause at 30 days, 6 and 12 months
Target Lesion Revascularization
Clinically-driven TLR at 30 days, 6 and 12 months TLR at 6 and 12 months
Target Vessel Revascularization
Clinically-driven TVR at 30 days, 6 and 12 months TVR at 6 and 12 months
Major target limb amputation
Major target limb amputation at 30 days, 6 and 12 months
Thrombosis at the target lesion site
Thrombosis at the target lesion site at 30 days, 6 and 12 months
Time to first clinically-driven Target Lesion Revascularization
Time to first clinically-driven TLR through 12 months post-index procedure
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.
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.
Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion
Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion at 6 and 12 months post-index procedure, or at the time of reintervention prior to any pre-specified time point
Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion
Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion at 6 and 12 months post-index procedure, or at the time of reintervention prior to any pre-specified time point
Walking capacity assessment
Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 30 days, 6 and 12 months
Walking distance
Walking distance as assessed by 6 Minute Walk Test (6MWT) at 30 days, 6 and 12 months as change from baseline
Quality of life assessment
Quality of life assessment by EQ5D questionnaire at 30 days, 6 and 12 months as change from baseline
Device success
Device success is defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).
Procedural success
Procedural success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by core lab assessment.
Clinical success
Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge.
Days of hospitalization due to the target lesion
Days of hospitalization due to the target lesion from procedure through 6 and 12 months
Full Information
NCT ID
NCT02118532
First Posted
April 11, 2014
Last Updated
December 29, 2016
Sponsor
Medtronic Endovascular
1. Study Identification
Unique Protocol Identification Number
NCT02118532
Brief Title
The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population
Official Title
The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to confirm that the IN.PACT Admiral is safe and effective for the interventional treatment of new and non-stented restenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in Chinese patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
Atherosclerosis, Superficial Femoral Artery, Proximal Popliteal Artery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IN.PACT Admiral
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Intervention Description
IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter originally developed, approved and commercialized by Invatec Technology Center GmbH is the investigational medical device used in the study. Medtronic Inc. acquired Invatec on April 21, 2010. Medtronic
Primary Outcome Measure Information:
Title
Primary effectiveness endpoint: Primary patency within 12 months post-index procedure
Description
Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR)1 and freedom from restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.4
Time Frame
12 months
Title
Primary Safety Endpoint
Description
A composite of freedom from device- and procedure-related mortality, freedom from major target limb amputation and freedom from clinicallydriven TLR within 30-day post-index procedure
Time Frame
30 days post-index procedure
Secondary Outcome Measure Information:
Title
Major Adverse Events
Description
MAE is defined as all-cause mortality, clinically-driven Target Vessel Revascularization (TVR), major target limb amputation or thrombosis at the target lesion site, through 12 months
Time Frame
12 months
Title
Death of any cause
Description
Death of any cause at 30 days, 6 and 12 months
Time Frame
30 days, 6 and 12 months
Title
Target Lesion Revascularization
Description
Clinically-driven TLR at 30 days, 6 and 12 months TLR at 6 and 12 months
Time Frame
30 days, 6 and 12 months
Title
Target Vessel Revascularization
Description
Clinically-driven TVR at 30 days, 6 and 12 months TVR at 6 and 12 months
Time Frame
30 days, 6 and 12 months
Title
Major target limb amputation
Description
Major target limb amputation at 30 days, 6 and 12 months
Time Frame
30 days, 6 and 12 months
Title
Thrombosis at the target lesion site
Description
Thrombosis at the target lesion site at 30 days, 6 and 12 months
Time Frame
30 days, 6 and 12 months
Title
Time to first clinically-driven Target Lesion Revascularization
Description
Time to first clinically-driven TLR through 12 months post-index procedure
Time Frame
12 months
Title
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 and 12 months
Title
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 and 12 months
Title
Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion
Description
Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion at 6 and 12 months post-index procedure, or at the time of reintervention prior to any pre-specified time point
Time Frame
6 and 12 months
Title
Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion
Description
Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion at 6 and 12 months post-index procedure, or at the time of reintervention prior to any pre-specified time point
Time Frame
6 and 12 months
Title
Walking capacity assessment
Description
Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 30 days, 6 and 12 months
Time Frame
30 days, 6 and 12 months
Title
Walking distance
Description
Walking distance as assessed by 6 Minute Walk Test (6MWT) at 30 days, 6 and 12 months as change from baseline
Time Frame
30 days, 6 and 12 months
Title
Quality of life assessment
Description
Quality of life assessment by EQ5D questionnaire at 30 days, 6 and 12 months as change from baseline
Time Frame
30 days, 6 and 12 months
Title
Device success
Description
Device success is defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).
Time Frame
Post procedure
Title
Procedural success
Description
Procedural success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by core lab assessment.
Time Frame
Post procedure
Title
Clinical success
Description
Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge.
Time Frame
Post procedure
Title
Days of hospitalization due to the target lesion
Description
Days of hospitalization due to the target lesion from procedure through 6 and 12 months
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years and ≤ 85 years.
Subject with documented diagnosis of peripheral arterial disease (PAD) classified as Rutherford class 2-3-4 in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) above the knee, located in the arterial segment starting at least 1 cm beyond the Common femoral artery (CFA) bifurcation between the superficial and profunda femoris arteries (proximal anatomical landmark to the distal P1 segment of the popliteal artery at the level of the proximal edge of the patella (distal anatomical landmark).
Target lesion consists of a single de novo or non-stented restenotic lesion (or a tandem lesion) or is a combination lesion
Reference vessel diameter ≥ 4 mm and ≤ 7 mm by visual estimate.
Subject able to walk without assistive devices (e.g. walker, cane).
If subject has ipsilateral/contralateral iliac disease that requires treatment during the index procedure
Angiographic evidence of adequate distal run-off to the foot (at least one native calf vessel [posterior tibial, anterior tibial, or peroneal arteries] is patent, defined as < 50% diameter stenosis).
Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before index procedure and willing to use a reliable method of birth control for the duration of the study or must have documented adequate birth control.
Signed and dated Patient Informed Consent (PIC) form.
Understands and accepts the duration of the study and is able and willing to comply with all requirements, including follow-up visits and evaluations.
Life expectancy, in the Investigator's opinion, of at least 12 months.
Exclusion Criteria:
In the investigator's opinion subject is unlikely to comply with the followup schedule.
Stroke or STEMI within the 3 months prior to index procedure.
Either local or systemic thrombolytic therapy within 48 hours prior to the index procedure.
Inability to tolerate oral anticoagulation therapy (blood thinners such as warfarin) while on concomitant dual antiplatelet therapy (DAPT).
Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
Breastfeeding woman.
Chronic renal insufficiency with serum creatinine > 2.5 mg/dL within 14 days prior to index procedure.
WBC < 3.0 (3,000 cells/mm3) within 14 days prior to index procedure.
PLT count < 80,000 cells/mm3 or > 700,000 cells/mm3 within 14 days prior to index procedure.
Known or suspected active systemic infection evidenced by WBC > 14.0 (14000/mm3) within 14 days prior to index procedure.
Diagnosed with bleeding diatheses or hypercoagulable state.
Subject is enrolled in another investigational device, drug or biologic study or subject was previously enrolled to the IN.PACT SFA China trial.
Any major (e.g., cardiac. peripheral, abdominal) surgical procedure or intervention performed within 30 days prior to the index procedure.
Any major (e.g., cardiac. peripheral, abdominal) elective procedure or intervention within 30 days post index procedure.
Contralateral SFA/PPA disease requiring treatment in the same setting as index procedure.
Presence of additional lesions in the target vessel that require treatment during index procedure but do not meet the definitions of tandem lesions.
Target lesion is an in-stent or post-DEB restenosis or has been previously treated with bypass surgery.
Failure to successfully cross the target lesion with a guide wire
Lesion within or adjacent to an aneurysm.
Acute or sub-acute thrombus in the target vessel.
Angiographic evidence of severe calcification
Target lesion known in advance of enrollment to require treatment with alternative therapy such as drug-eluting stent (DES), drug-eluting balloon (DEB), laser, atherectomy, cryoplasty, re-entry devices, cutting/scoring balloon, brachytherapy. Use of embolic protection devices is also prohibited.
Pre-dilation resulted in a major ( ≥ Grade D) flow-limiting dissection (observed on 2 orthogonal views) or residual stenosis > 70% and translesional peak gradient > 10mm Hg.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong Chen, Prof
Organizational Affiliation
Vascular Department Anzhen Hospital, Capital Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Guo, Prof
Organizational Affiliation
Vascular Department 301 Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
301 Hospital/Chinese PLA General Hospital
City
Beijing
Country
China
Facility Name
Anzhen Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
West China Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
The First Affiliated Hospital, Dalian Medical University
City
Dalian
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
Country
China
Facility Name
The 1stAffiliated Hospital of Sun Yat-sen University
City
Guangzhou
Country
China
Facility Name
The 2nd Affiliated Hospital of Harbin Medical University
City
Harbin
Country
China
Facility Name
The first affiliated Hospital of Harbin Medical University
City
Harbin
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
Country
China
Facility Name
Shanghai 9th People Hospital Affiliated Shanghai Jiao Tong University School of Medecine
City
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
Country
China
12. IPD Sharing Statement
Citations:
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
31204595
Citation
Chen Z, Guo W, Jiang W, Wang F, Fu W, Zou Y, Deckers S, Li P, Popma JJ, Jaff MR. IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population. J Endovasc Ther. 2019 Aug;26(4):471-478. doi: 10.1177/1526602819852084. Epub 2019 Jun 17.
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
Learn more about this trial
The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population
We'll reach out to this number within 24 hrs