Evaluation of the GORE TIGRIS Vascular Stent

Study Overview
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Brief Summary
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The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of patients with symptomatic peripheral arterial disease (PAD).

Official Title
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Evaluation of the GORE TIGRIS Vascular Stent in the Treatment of Atherosclerotic Lesions of the Superficial Femoral and Proximal Popliteal Arteries

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: TIGRIS Vascular Stent
* Device: BARD LifeStent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rutherford Class 2 - 4. Abnormal ankle brachial index (ABI ≤0.9). At least 21 years of age. Reasonable expectation of survival of at least 12 months after the procedure. Male, infertile female, or female practicing an effective method of preventing pregnancy. One de novo or restenotic lesion of the SFA/PPA with a cumulative length visually estimated to be ≤24cm Arteries with reference vessel diameter of 4.0 - 6.5 mm within the SFA/PPA, estimated visually. Angiographic evidence of at least one patent tibial artery (<50% stenosis angiographically). Guidewire has successfully traversed the lesion to be treated and is within the true lumen of the distal vessel. Lesion has been pre-dilated before stent deployment. Exclusion Criteria: Prior enrollment in this study. Vascular access/catheterization in the target leg within 30 days of study enrollment. Prior treatment of the SFA/PPA in the target leg with stenting or bypass. Flow-limiting aortoiliac disease. Additional ipsilateral femoropopliteal or tibial disease, outside of the lesion to be stented, requiring intervention. Arterial aneurysm in the target leg. Co-morbid conditions which would preclude compliance with study protocol. Obstructive or occlusive non-atherosclerotic disease. Creatinine greater than 2.5 mg/dl. Amputation above the metatarsals, resulting from vascular disease, in the target leg. Septicemia or uncontrolled infection. Contraindication to anticoagulation or antiplatelet therapy, including allergy to heparin, or history of heparin induced thrombocytopenia (HIT), or a positive platelet factor 4 (PF4) antibody assay. Abnormal platelet levels, i.e., platelet count at Baseline less than 80,000/microliter. History of coagulopathy.

Ages Eligible for Study
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Minimum Age: 21 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIGRIS Vascular Stent<br>GORE TIGRIS Vascular Stent | Device: TIGRIS Vascular Stent<br>* Implant<br>|
| Active Comparator: BARD LifeStent<br>BARD LifeStent | Device: BARD LifeStent<br>* Implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days | Defined as any adverse event (occurring within 30 days of the initial procedure) that causes death, target vessel revascularization (TVR), and amputation above the metatarsals in the treated leg (index limb amputation). | 30 Days | 
| Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months | Primary patency is defined by a Peak Systolic Velocity Ratio (PSVR) ≤2.5 without target lesion revascularization (TLR) at 12 months after implantation. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Procedural Success | Successful device implantation with a residual stenosis <30% without acute (within 48 hours) serious adverse events. | Within 48 hours of initial device implant | 
| Number of Participants With Device Success | Successful delivery of stent to the intended site and successful stent deployment. | Immediately following initial device implant (usually within a few minutes to an hour). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, Superficial Femoral Artery, Proximal Popliteal Artery, PAD, SFA, PPA, Stent, Gore, Bare Metal Stent, LifeStent, atherosclerosis, Heparin, claudication, leg pain