SuperNOVA Clinical Stenting Trial

Study Overview
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Brief Summary
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The primary objective of this clinical study is to determine whether the Innova Stent System shows acceptable performance in long-term (12-month) safety rates and vessel patency when treating femoropopliteal lesions.

Detailed Description
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Atherosclerosis is a systemic disease that has become increasingly recognized in the expanding elderly population as a significant cause of morbidity and mortality. Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms ranging from intermittent claudication to ischemic rest pain and critical ischemia with major tissue loss. Typically, femoropopliteal lesions have been difficult to successfully treat with endovascular therapy because the disease is often diffuse and located in an area of the body subject to significant mobility stresses such as extension, contraction, compression, elongation, flexion and torsion. The SuperNOVA clinical study is a prospective, single arm, controlled, multicenter, global study. Approximately 50 centers located in the United States, Europe, Canada and/or Australia are expected to participate in recruiting patients needing treatment of lesions in their femoropopliteal arteries. A maximum of 300 subjects will be enrolled to ensure that a minimum of 296 stented segments are treated with the Innova Stent System.

Official Title
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Stenting of the Superficial Femoral (SFA) and Proximal Popliteal Arteries (PPA) With the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System

Conditions
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Atherosclerosis of Native Arteries of the Extremities, Unspecified

Intervention / Treatment
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* Device: Stent implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects age 18 and older Chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4 Stenotic, restenotic (from angioplasty only) 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 </= 7mm Total lesion length (or series of lesions) >/=30mm and </= 190 mm (note: tandem lesions may be treated, provided that the tandem lesion segment can be covered with only one stent) If lesion is restenotic, PTA treatment must be >3 months prior to stent placement 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 Subject (or Legal Guardian) 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 Exclusion Criteria: Previous stent placement in the target vessel Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease Subjects who have undergone prior percutaneous transluminal angioplasty (PTA) in the target SFA/PPA in the past 3 months Use of atherectomy devices or other adjunctive treatment in the SFA/PPA during the index procedure History of major amputation in the same limb as the target lesion Life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical study, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical study Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated. Intolerance to antiplatelet, anticoagulant, or thrombolytic medications Platelet count <150,000 mm3 or >600,000 mm3 Concomitant renal failure with a serum creatinine >2.0 mg/dL Receiving dialysis or immunosuppressant therapy Pregnancy Current participation in another investigational drug or device clinical study Known allergy to Nitinol Septicemia at the time of the index procedure Presence of other hemodynamically significant outflow lesions requiring intervention within 30 days of the index procedure Target lesion is within or near an aneurysm Acute ischemia and/or acute thrombosis of the SFA/PPA Persistent, intraluminal thrombus of the proposed target lesion post- thrombolytic therapy Perforated vessel as evidenced by extravasation of contrast media Heavily calcified lesions

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: Stent<br>Stent implantation into SFA/PPA | Device: Stent implantation<br>* Stent implantation during the index procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint and Components | The safety endpoint assesses the occurrence of Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months | 1 month for death, 12 months for target limb major amputation , and target lesion revascularization | 
| Co-Primary Efficacy Endpoints | The co-primary efficacy endpoints assess vessel primary patency at 12 months post-procedure. The co-primary efficacy analysis (1) will assess vessel primary patency in stented segments intended to be treated with core matrix stents (20 to 150 mm). The co-primary efficacy analysis (2) will assess vessel primary patency in stented segments intended to be treated with the entire stent matrix (20 to 200 mm). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety Endpoint and Components | The secondary safety endpoint assesses the occurrence of Major Adverse Events (MAEs) through 30 days. MAEs will include all causes of death, target limb major amputation and/or target lesion revascularization through 1 month | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), lower extremities, Stenting