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

NCT06124755 | Not Yet Recruiting DMC

• 1 other identifier: The Virtue study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

Viabahn endoprosthesis; Drug-coated balloon

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Procedural success

  Immediately after interventional surgery

• Primary assisted patency

  24-month

• Secondary patency

  24-month

• Clinically-driven target vessel revascularization (CD-TVR)

  24-month

• Primary sustained clinical improvement

  24-month

Study Arms (2)

Viabahn endoprosthesis group

EXPERIMENTAL

Femoropopliteal lesions treated with Viabahn endoprosthesis.

Device: Viabahn endoprosthesis group

Drug-coated balloon group

ACTIVE COMPARATOR

Femoropopliteal lesions treated with drug-coated balloon endoprosthesis.

Device: Drug-coated balloon group

Interventions

Viabahn endoprosthesis group DEVICE

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

Viabahn endoprosthesis group

Drug-coated balloon group DEVICE

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

Drug-coated balloon group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Qihong Ni, M.D.

CONTACT

+8615801900772; niqihong1989@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 9, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

CN (1)