Evaluation of the GORE TIGRIS Vascular Stent

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

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).

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.