The US Study for Evaluating Endovascular Treatments of Lesions in the Superficial Femoral Artery & Proximal Popliteal by Using the Protege Everflex Nitinol Stent System II (DURABILITY II)
Description of Research
The purpose of this study is to determine if the Ever Flex stent is more safe and effective than percutaneous transluminal angioplasty (PTA) when used in subjects with atherosclerotic narrowing of the arteries in the leg above the knee.
The study is designed to treat patients who may have been treated previously with a balloon angioplasty (PTA) and are experiencing recurrence of the narrowing, or those who have not been treated previously. Patients who require a procedure to improve the blood flow to their legs based on results of their standard pre-testing exams that determine severity of disease will be considered for the study.