Balloon Angioplasty Versus Primary Stenting for the Treatment of Femoropopliteal Artery Chronic Total Occlusions

Inclusion Criteria: * Age \>/= 30 years, both genders, no healthy volunteers * Negative pregnancy test for women of childbearing age * Symptomatic leg ischemia by Rutherford/Becker Classification (category 3, 4 or 5), i.e. lifestyle-limiting claudication or critical limb ischemia Single completely occluded de-novo superficial femoral artery lesion (femoral artery CTO target lesion) * Combined overall length of treatable occluded SFA lesion \>/= 4.0 cm to \</= 15.0 cm, by visual estimate. The occlusion must be treatable with no more than two stents, minimizing the stent overlap. * Randomization process before successful subintimal or intraluminal recanalization of the lesion in order to evaluate technical success * Use of re-entry devices at the discretion of the operator * All lesions are to be located at least three centimeters (3 cm) proximal to the superior edge of the patella * Reference vessel diameter (RVD) \>/= 4.0 mm and \</ 6.0 mm by visual assessment * At least 1 patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (\< 50% stenosis) to the ankle or foot * Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined \> 50% stenosis of the iliac or common femoral artery) lesions must be successfully treated prior to treatment of the target lesion * Bilateral obstructive SFA disease is eligible for enrollment into the study * Patient or authorized representative must provide written inf…