Evaluation of the GORE TIGRIS Vascular Stent

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.