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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Viabahn endoprosthesis group; Device: Drug-coated balloon group

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qihong Ni, M.D.; Phone Number: +8615801900772; Email: niqihong1989@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • RenJi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Viabahn endoprosthesis group; Femoropopliteal lesions treated with Viabahn endoprosthesis.	Device: Viabahn endoprosthesis group; Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by Viabahn endoprosthesis.
Active Comparator: Drug-coated balloon group; Femoropopliteal lesions treated with drug-coated balloon endoprosthesis.	Device: Drug-coated balloon group; Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by drug-coated balloon.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Procedural success is defined as technical or device success without major adverse events during the hospital stay.	Immediately after interventional surgery
Primary assisted patency	Primary assisted patency is defined as maintaining patency in the target vessel after a repeat intervention to regain patency prior to complete occlusion.	24-month
Secondary patency	Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.	24-month
Clinically-driven target vessel revascularization (CD-TVR)	clinically-driven target vessel revascularization (CD-TVR) is defined as repeat intervention performed during enrollment in the clinical study.	24-month
Primary sustained clinical improvement	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.	24-month
Secondary sustained clinical improvement	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.	24-month
Vasc quality of life score	Change of Vasc quality of life score	24-month

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Fudan University; Huashan Hospital; Chengdu University of Traditional Chinese Medicine; Xuanwu Hospital, Beijing; First Affiliated Hospital of Zhejiang University; Second Affiliated Hospital of Soochow University; Qingdao Haici Hospital; Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology; Xiamen Cardiovascular Hospital, Xiamen University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Estimated): November 9, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Drug-coated balloon; Viabahn endoprosthesis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: The Virtue study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No