The Efficacy of Heparin-boned Viabahn Endoprosthesis and Paclitaxel-coated Balloons for Complex Femoropopliteal Lesions

This is a multicenter, prospective, 1:1 randomized clinical trial with clinical and image follow-up for two years post-procedure. Approximately 60 subjects will be enrolled and randomized into a Viabahn preferred group (study arm) or drug-coated balloons (DCB) group (control arm); Each group will include 30 patients. All enrolled patients will be followed up for 12 months to assess the incidence of restenosis by duplex ultrasound and major adverse events. Follow-up visits occur at 12 and 24 months, as well as telephone visits after 1, 6, 9 and 24 months.

Inclusion criteria

• The patient presented a score from 2 to 5 following Rutherford classification.
• The patient is willing to comply with specified follow-up evaluations at the specified times.
• The patient is ≥ 18 years old.
• Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
• The patient has a projected life expectancy of at least 24 months
• Before enrolment, the guidewire has crossed the target lesion
• Subject has a de novo or restenotic lesion with ≥ 70% stenosis in femoropopliteal artery, and for de novo lesion, the total lesion length ≥ 25cm, or chronic total occlusion (CTO) length ≥15cm.
• There is angiographic evidence of patent infrageniculate popliteal artery and at least one distal runoff to the foot.
• Origin and proximal 1 cm of Superficial Femoral Artery (SFA) are patent.
• Reference vessel diameter (RVD) ≥ 4 mm by visual estimation.

Exclusion criteria

• Previous bypass surgery or stenting in the target vessel
• Patients who exhibit acute intraluminal thrombus at the target lesion vessel
• Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
• Pregnant women or Female patients with potential childbearing
• Use of thrombectomy, atherectomy, or laser devices during the procedure
• Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
• The patient is currently participating in another investigational drug or device study that interferes with the study
• Significant renal dysfunction (Serum creatinine >3.0mg/dl)
• Patient with Known allergy to contrast media
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
• Femoral or popliteal aneurysm.
• Current peritoneal or hemodialysis.