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

Not yet recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT06752954
• Lead Sponsor: First Affiliated Hospital of Jinan University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2024-12-22
• Last Update Submitted: 2024-12-22
• Study Start: 2024-12-25
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary patency	12-month	Peak systolic velocity ratio (PSVR ≤2.4) without any repeat intervention.
Freedom from a composite of Major adverse events (MAEs)	12-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.
Primary assisted patency	12-month	Primary assisted patency is defined as maintaining patency in the target vessel after a repeat intervention to regain patency prior to complete occlusion.
Secondary patency	12-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.
Clinically-driven target vessel revascularization (CD-TVR)	12-month	clinically-driven target vessel revascularization (CD-TVR) is defined as repeat intervention performed during enrollment in the clinical study.
Primary sustained clinical improvement	12-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.
Secondary sustained clinical improvement	12-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.
Vasc quality of life score	12-month	Change of Vasc quality of life score