The Effectiveness of Covered Stent Viabahn and Drug-coated Balloon for Complex Femoropopliteal Artery Lesions

Jinan University

Status: Not yet enrolling

Conditions: Peripheral Arterial Disease

Treatments: Device: Viabahn endoprosthesis group; Device: Drug-coated balloon group

Study type: Observational

Funder types: Other

Identifiers

NCT06752954

The support study

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of the covered stent Viabahn in treating long de novo femoropopliteal lesions (stenosis ≥ 25 cm, total occlusion ≥ 15 cm) or in-stent restenosis compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent.

Full description

This is a multicenter, observational prospective cohort clinical trial with clinical and image follow-up for two years post-procedure. Approximately 200 subjects will be enrolled into a Viabahn group (observe arm) or drug-coated balloons (DCB) group (contrast arm); Each group will include 100 patients.

All enrolled patients will be followed up for 12 and 24 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, 3,6 and 9 months.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient is ≥ 18 years old.
2. Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
3. The patient is willing to comply with specified follow-up evaluations at the specified times.
4. The patient presented a score from 2 to 5 following Rutherford classification.
5. The patient has a projected life expectancy of at least 24 months
6. 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.

Exclusion criteria

1. Patients with known hypersensitivity or contraindication to any of the following medications: Contrast media, Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
2. Pregnant women or Female patients with potential childbearing
3. Patients who exhibit acute intraluminal thrombus at the target lesion vessel
4. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
5. The patient is currently participating in another investigational drug or device study that interferes with the study

Trial design

200 participants in 2 patient groups

Viabahn endoprosthesis group

Description:

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

Treatment:

Device: Viabahn endoprosthesis group

Drug-coated balloon group

Description:

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

Treatment:

Device: Drug-coated balloon group