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

NCT ID: NCT06124755

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2027-08-31

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Viabahn endoprosthesis group

Femoropopliteal lesions treated with Viabahn endoprosthesis.

Group Type: EXPERIMENTAL

Viabahn endoprosthesis group

Intervention Type: DEVICE

Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by Viabahn endoprosthesis.

Drug-coated balloon group

Femoropopliteal lesions treated with drug-coated balloon endoprosthesis.

Group Type: ACTIVE_COMPARATOR

Drug-coated balloon group

Intervention Type: DEVICE

Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by drug-coated balloon.

Interventions

Viabahn endoprosthesis group

Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by Viabahn endoprosthesis.

Intervention Type: DEVICE

Drug-coated balloon group

Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by drug-coated balloon.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Qingdao Haici Hospital

OTHER

Sponsor Role: collaborator

Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

Xiamen Cardiovascular Hospital, Xiamen University

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Renji Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Qihong Ni, M.D.

Role: CONTACT

niqihong1989@163.com

+8615801900772

Other Identifiers

The Virtue study

Identifier Type: -

Identifier Source: org_study_id