Comparing the Efficacy of Heparin-boned Viabahn@ Endoprosthesis and Paclitaxel-coated Balloons for Endovascular Treatment of Complex Femoropopliteal Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary patency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Primary patency
时间窗: 24-month
Peak systolic velocity ratio (PSVR ≤2.4) without any repeat intervention.
Freedom from a composite of Major adverse events (MAEs)
时间窗: 24-month
Freedom from MAEs is defined as freedom from clinically-driven target vessel revascularization (CD-TVR), major amputation, and all-cause of death
次要结局
- Procedural success(Immediately after interventional surgery)
- Secondary patency(24-month)
- Primary assisted patency(24-month)
- Primary sustained clinical improvement(24-month)
- Vasc quality of life score(24-month)
- Clinically-driven target vessel revascularization (CD-TVR)(24-month)
- Secondary sustained clinical improvement(24-month)