Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease

Who can take part

• Subject age ≥ 18
• Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing Rutherford category 2-4
• Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion
• Target lesion length is ≤ 30cm
• Target lesion is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle
• Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion. Total lesion length should not exceed 30 cm
• Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation
• Patency of at least one (1) infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery
• A guidewire has successfully traversed the target treatment segment

Who cannot take part

• Prior vascular surgery of the target lesion
• Stroke or heart attack within 3 months prior to enrollment
• Any surgical procedure or intervention performed within 30 days prior to or post index procedure
• Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices
• Enrolled in another investigational drug, device or biologic study
• Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
• Failure to successfully cross the target lesion
• Superficial femoropopliteal Artery or Proximal popliteal artery disease in the opposite leg that requires treatment at the index procedure
• Angiographic evidence of severe calcification
• Presence of fresh thrombus in the lesion
• Presence of aneurysm in the target vessel/s
• Presence of a stent in the target lesion
• Life expectancy of less than one year
• Rutherford classification of 0, 1, 5 or 6