The Efficacy of Heparin-boned Viabahn Endoprosthesis and Paclitaxel-coated Balloons for Complex Femoropopliteal Lesions
Key facts
- Where
- Shanghai, ChinaSee the site
Where in China
- RenJi HospitalShanghai, ChinaContact: Qihong Ni, M.D.No longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- RenJi Hospital
- Trial code
- NCT06124755
- Record updated
- 9 November 2023
- Original description
The purpose of this study is to evaluate the effectiveness of the Viabahn endoprosthesis for treating long femoropopliteal lesions (stenosis ≥ 25cm, occlusion ≥ 15cm) or recurrent in-stent restenosis compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent.Read full original descriptionShow less
Comparing the Efficacy of Heparin-boned Viabahn@ Endoprosthesis and Paclitaxel-coated Balloons for Endovascular Treatment of Complex Femoropopliteal Lesions
The purpose of this study is to evaluate the effectiveness of the Viabahn endoprosthesis for treating long femoropopliteal lesions (stenosis ≥ 25cm, occlusion ≥ 15cm) or recurrent in-stent restenosis compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent.
Inclusion: 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: Previous bypass surgery or stenting in the target vessel; The patient is currently participating in another investigational drug or device study that interferes with the study; Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy; Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion); Patient with Known allergy to contrast media; Significant renal dysfunction (Serum creatinine >3.0mg/dl); Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy; Patients who exhibit acute intraluminal thrombus at the target lesion vessel; Pregnant women or Female patients with potential childbearing; Use of thrombectomy, atherectomy, or laser devices during the procedure; Femoral or popliteal aneurysm; Current peritoneal or hemodialysis.