Status:
NOT_YET_RECRUITING
The Efficacy of Heparin-boned Viabahn Endoprosthesis and Paclitaxel-coated Balloons for Complex Femoropopliteal Lesions
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
Chengdu University of Traditional Chinese Medicine
Second Affiliated Hospital of Soochow University
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 Viaba...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06124755
Start Date
December 1 2023
End Date
August 31 2027
Last Update
November 9 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Renji Hospital
Shanghai, Shanghai Municipality, China, 200127