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.