Comparison of the Effectiveness of Viabahn® Vs. Drug-Coated Balloon With/without Bail-Out Bare Metal Stent in Treating Complicated Femoropopliteal Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 200
- Primary Endpoint
- Primary patency
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 is willing to comply with specified follow-up evaluations at the specified times.
- •The patient presented a score from 2 to 5 following Rutherford classification.
- •The patient has a projected life expectancy of at least 24 months
- •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
- •Patients with known hypersensitivity or contraindication to any of the following medications: Contrast media, Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
- •Pregnant women or Female patients with potential childbearing
- •Patients who exhibit acute intraluminal thrombus at the target lesion vessel
- •Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
- •The patient is currently participating in another investigational drug or device study that interferes with the study
Outcomes
Primary Outcomes
Primary patency
Time Frame: 12-month
Peak systolic velocity ratio (PSVR ≤2.4) without any repeat intervention.
Freedom from a composite of Major adverse events (MAEs)
Time Frame: 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 Outcomes
- Procedural success(Immediately after interventional surgery)
- Primary assisted patency(12-month)
- Secondary patency(12-month)
- Clinically-driven target vessel revascularization (CD-TVR)(12-month)
- Primary sustained clinical improvement(12-month)
- Secondary sustained clinical improvement(12-month)
- Vasc quality of life score(12-month)
Investigators
Chengzhi Li
Doctor of Medicine
First Affiliated Hospital of Jinan University