NCT02580955Unknown3 期
ReFlow Study, a Physician-initiated Trial Investigating the Efficacy of the LegFlow Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter for the Treatment of Femoropopliteal Lesions Longer Than 15cm (TASC C&D Lesions).
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Primary Patency at 12 months, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months.
研究概览
简要总结
A physician initiated trial investigating the LEGFLOW Paclitaxel-Eluting Peripheral Balloon dilatation catheter for the treatment of femoropopliteal lesions longer than 15cm.
Objective: to evaluate the short-term outcome of the treatment by means of the LEGFLOW Paclitaxel-Eluting Peripheral BAlloon Dilattaion for the treatment of long femoropopliteal lesions (TASC C&D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient presenting a score from 2 to 5 following Rutherford classification
- •Patient is willing to comply with specified follow-up evaluations at the specified times
- •Patient is >18 years old
- •Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- •Patient has a projected life expectancy of at least 12 months
- •Prior to enrolment, the guidewire has crossed target lesion
- •Patient is eligible for treatment with the LEGFLOW Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter
- •Male, infertile female or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
- •De novo lesion located in the femoropopliteal arteries suitable for endovascular therapy
- •The target lesion is located within the native femoropopliteal artery
- •The length of the target lesion is > 150mm and considered as TASC C or D lesion according to the TASC II classification.
- •The target lesion has angiographic evidence of stenosis > 50% or occlusion which can be passed with standard guidewire manipulation
- •Target vessel diameter visually estimated is >4mm and <6.5 mm
- •There is angiographic evidence of at least one-vessel-runoff to the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention
排除标准
- •Patient refusing treatment
- •Presence of a stent in the target lesion that was placed during a previous procedure
- •Untreated flow-limiting inflow lesions
- •Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
- •Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
- •Previous bypass surgery in the same limb
- •Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- •Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
- •Perforation at the angioplasty site evidenced by extravasation of contrast medium
- •Patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
- •Patients with uncorrected bleeding disorders
- •Aneurysm located at the level of the SFA
- •Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
- •Severe medical comorbidities (untreated CAD/CHF, sever COPD, metastatic malignancy, dementia, etc.) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
- •Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
- •Septicemia or bacteremia
- •Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis >30% or ipsilateral iliac treatment conducted after the target lesion procedure
- •Use of thrombectomy, atherectomy or laser devices during procedure
- •Any patient considered to be hemodynamically unstable at onset of procedure
- •Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
- •Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period
研究组 & 干预措施
LEGFLOW DCB
Experimental
patients treated with the LEGFLOW Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter
干预措施: LEGFLOW DCB (Device)
结局指标
主要结局
Primary Patency at 12 months, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months.
时间窗: 12 months
次要结局
- Serious adverse events(12 months)
- Freedom from TLR at 1,6 and 12-month follow-up(1 month, 6 months, 12 months)
- Primary Patency rate at 1 & 6 month follow-up(1 month, 6 months)
- Clinical success at follow-up, defined as an improvement of Rutherford classification at all follow-up time points(12 months)
- Technical success(during procedure, at baseline)
研究者
研究点 (4)
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