Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project

Study Overview
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Brief Summary
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To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA) lesions.

Official Title
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Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project With Boston Scientific's Innova Drug Eluting Stent

Conditions
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Atherosclerosis of Native Arteries of the Extremities

Intervention / Treatment
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* Device: The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects age 18 and older Subject (or Legal Guardian if applicable) has signed the consent form and is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4 Stenotic, restenotic (from angioplasty only, previous treatment with drug coated balloon is not allowed) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery: Degree of stenosis ≥70% by visual angiographic assessment Vessel diameter ≥ 4 and ≤ 6mm Total lesion length (or series of lesions) ≥30 mm and ≤110 mm (Note: tandem lesions may be treated, provided that the tandem lesion segment can be covered with only one stent) Target lesion located at least three centimeters above the inferior edge of the femur Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot

Ages Eligible for Study
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Minimum Age: 18 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: Test device arm (DES SFA)<br>Patients in this arm will receive the study device: the Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA) | Device: The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)<br>* Drug-eluting SFA self-expanding stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency | Primary patency of target lesion at 9-months assessed by duplex ultrasound (DUS) as adjudicated by an independent core laboratory. Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without target lesion revascularization (TLR) or, bypass of the target lesion. | 9-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atherosclerosis, SFA, PPA, lower extremities, stenting, paclitaxel