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

Not Applicable

Not yet recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Drug-coated balloon group; Device: Viabahn endoprosthesis group

• Registration Number: NCT06124755
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-06
• Last Update Submitted: 2023-11-06
• Study First Posted: 2023-11-09
• Last Update Posted: 2023-11-09
• Study Start: 2023-12-01
• Primary Completion: 2026-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug-coated balloon group	Drug-coated balloon group	Femoropopliteal lesions treated with drug-coated balloon endoprosthesis.
Viabahn endoprosthesis group	Viabahn endoprosthesis group	Femoropopliteal lesions treated with Viabahn endoprosthesis.

Primary Outcome Measures

Name	Time	Method
Primary patency	24-month	Peak systolic velocity ratio (PSVR ≤2.4) without any repeat intervention.
Freedom from a composite of Major adverse events (MAEs)	24-month	Freedom from MAEs is defined as freedom from clinically-driven target vessel revascularization (CD-TVR), major amputation, and all-cause of death

Secondary Outcome Measures

Name	Time	Method
Procedural success	Immediately after interventional surgery	Procedural success is defined as technical or device success without major adverse events during the hospital stay.
Secondary patency	24-month	Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.
Primary assisted patency	24-month	Primary assisted patency is defined as maintaining patency in the target vessel after a repeat intervention to regain patency prior to complete occlusion.
Primary sustained clinical improvement	24-month	Defined as a sustained upward shift of at least one category on the Rutherford classification without the need for repeated target lesion revascularization (TLR) in surviving patients.
Vasc quality of life score	24-month	Change of Vasc quality of life score
Clinically-driven target vessel revascularization (CD-TVR)	24-month	clinically-driven target vessel revascularization (CD-TVR) is defined as repeat intervention performed during enrollment in the clinical study.
Secondary sustained clinical improvement	24-month	Defined as a sustained upward shift of at least one category on the Rutherford classification3, including the need for repeated target lesion revascularization (TLR) in surviving patients.

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China