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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atherosclerosis

Intervention / Treatment
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* Device: IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IN.PACT Admiral<br> | Device: IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 
| 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 | 30 days post-index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 
| Death of any cause | Death of any cause at 30 days, 6 and 12 months | 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 | 30 days, 6 and 12 months | 
| Target Vessel Revascularization | Clinically-driven TVR at 30 days, 6 and 12 months TVR at 6 and 12 months | 30 days, 6 and 12 months | 
| Major target limb amputation | Major target limb amputation at 30 days, 6 and 12 months | 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 | 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 | 12 months | 
| 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. | 6 and 12 months | 
| 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. | 6 and 12 months | 
| 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 | 6 and 12 months | 
| 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 | 6 and 12 months | 
| Walking capacity assessment | Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 30 days, 6 and 12 months | 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 | 30 days, 6 and 12 months | 
| Quality of life assessment | Quality of life assessment by EQ5D questionnaire at 30 days, 6 and 12 months as change from baseline | 30 days, 6 and 12 months | 
| 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). | Post procedure | 
| Procedural success | Procedural success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by core lab assessment. | Post procedure | 
| 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. | Post procedure | 
| Days of hospitalization due to the target lesion | Days of hospitalization due to the target lesion from procedure through 6 and 12 months | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Superficial Femoral Artery, Proximal Popliteal Artery