Rapid Exchange Devices Observational Registry. (RXRegistry)

Inclusion Criteria:

• Patients with symptomatic one or two legs ischemia, requiring treatment of SFA or popliteal artery
• Rutherford classification 2-5
• Single lesion with recoiling/dissection/restenosis after balloon angioplasty or de novo lesions with stenosis or occlusion,
• Target vessel reference diameter ≥4mm and ≤7mm (by visual estimate)
• At least one patent (less than 50% stenosis) tibioperoneal run-off vessel confirmed by baseline angiography
• Patient is suitable candidate for femoral-popliteal artery bypass surgery

Exclusion Criteria:

• Female of child-bearing potential.
• Previous bypass surgery
• In stent restenosis as a target lesion
• Scheduled staged procedure of multiple lesions within the ipsilateral iliac or popliteal arteries within 30 days after index procedure.
• Co-existing aneurysmal disease of the abdominal aorta, iliac or popliteal arteries
• Acute thrombophlebitis or deep venous thrombosis
• Hemodynamic instability
• Untreated inflow disease of the ipsilateral pelvic arteries (more than 50 percent stenosis or occlusion),
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
• Known intolerance to study medications, contrast agents or nitinol.