The US Study for Evaluating Endovascular Treatments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By using the Protégé Everflex Nitinol Stent System II
ID Number 08-0608Principal Investigator(s)
Department(s) or Division(s)
This is a prospective, multi-center, non-randomized, single arm study to compare PTA (Percutaneous Transluminal Angioplasty) and primary stenting using a single Everflex stent versus performance goals of PTA alone in the treatment of superficial femoral artery (SFA) and proximal popliteal lesions 7-13 cm long in subjects with Rutherford clinical categories 2-4. The safety and effectiveness performance goals are based on the aggregate clinical data of PTA from randomized trials submitted to the FDA in pre-market approval applications and from published randomized trials.
Recruiting Patients: No