Evaluation of the GORE TIGRIS Vascular Stent in the Treatment of Atherosclerotic Lesions
Brief Description Of Study
The purpose of this Study is to determine the safety and effectiveness of the Study Device. Adult patients with symptoms of obstructive peripheral artery disease in the superficial femoral and/or proximal popliteal artery (SFA), (the main artery in the upper leg) will be invited to participate. The standard treatment for this condition is the insertion of a permanently implanted, self expanding, vascular stent (stent) to hold the blockage in the leg open. Two different stents will be used in the Study. One is the TIGRIS Vascular Stent (the Study Device), manufactured by W. L. Gore and Associates, Inc. (Flagstaff, AZ). The other is the LifeStent Vascular Stent (the Control), manufactured by Bard Peripheral Vascular (Tempe, AZ). Performance of the Study Device will be compared to that of the Control device. Patients with de novo or restenotic superficial femoral/proximal popliteal artery lesions; 24.0 cm in length; arterial reference diameter 4.0-6.5 mm are eligible to participate.