Clinical trial NCT06124755: The Efficacy of Heparin-boned Viabahn Endoprosthesis and Paclitaxel-coated Balloons for Complex Femoropopliteal Lesions
Official title: Comparing the Efficacy of Heparin-boned Viabahn@ Endoprosthesis and Paclitaxel-coated Balloons for Endovascular Treatment of Complex Femoropopliteal Lesions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Viabahn endoprosthesis
Drug-coated balloon
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Chengdu University of Traditional Chinese Medicine
name: Second Affiliated Hospital of Soochow University
name: First Affiliated Hospital of Zhejiang University
name: Xuanwu Hospital, Beijing
name: Qingdao Haici Hospital
name: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Fudan University
name: Huashan Hospital
name: Xiamen Cardiovascular Hospital, Xiamen University
First posted: 2023-11-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent.

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 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.

Eligibility criteria: Inclusion Criteria:

1. The patient presented a score from 2 to 5 following Rutherford classification.
2. The patient is willing to comply with specified follow-up evaluations at the specified times.
3. The patient is ≥ 18 years old.
4. Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
5. The patient has a projected life expectancy of at least 24 months
6. Before enrolment, the guidewire has crossed the target lesion
7. 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.
8. There is angiographic evidence of patent infrageniculate popliteal artery and at least one distal runoff to the foot.
9. Origin and proximal 1 cm of Superficial Femoral Artery (SFA) are patent.
10. Reference vessel diameter (RVD) ≥ 4 mm by visual estimation.

Exclusion Criteria:

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

Primary outcomes:
measure: Primary patency
timeFrame: 24-month
measure: Freedom from a composite of Major adverse events (MAEs)
timeFrame: 24-month
Secondary outcomes:
measure: Procedural success
timeFrame: Immediately after interventional surgery
measure: Primary assisted patency
timeFrame: 24-month
measure: Secondary patency
timeFrame: 24-month
measure: Clinically-driven target vessel revascularization (CD-TVR)
timeFrame: 24-month
measure: Primary sustained clinical improvement
timeFrame: 24-month
measure: Secondary sustained clinical improvement
timeFrame: 24-month
measure: Vasc quality of life score
timeFrame: 24-month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References: