NCT01630070已完成2 期
A Prospective, Multi-center, Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent in the Treatment of Atherosclerotic Tibial-peroneal Arteries
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 10
- 主要终点
- Primary patency
研究概览
简要总结
The objective of this clinical study is to evaluate the immediate and long-term (up to 12 month) safety and effectiveness of a Nitinol Self-Expanding Paclitaxel-Eluting stent for the treatment of patients with critical limb ischemia (i.e. rest pain or non-healing foot ulcers) due to the presence of arterial lesions in the below-the-knee arteries of maximally 50mm long.
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 with rest pain or minor tissue loss (Rutherford Clinical Category 4 or 5)
- •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
- •Patient is eligible for treatment with a Self-Expanding Paclitaxel-Eluting stent
- •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
- •Evidence at screening of ≥50% de novo lesion (or restenosis after previous PTA) in the infrapopliteal arteries, confirmed by angiography
- •Reference vessel diameter visually estimated to be ≥3.0mm and ≤4.5mm
- •Identifiable distal target vessel which upon completion of the intervention, is anticipated to provide reconstitution of blood flow to the foot.
- •Guidewire successfully traversed lesion
- •Length of target lesion is <50mm
排除标准
- •Untreated flow-limiting inflow lesions
- •Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
- •Has had a previous peripheral bypass affecting the target limb
- •Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
- •Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
- •Patient has a contra-indication or known untreated allergy to anti-platelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used
- •Patient has hypersensitivity to contrast or device material that cannot be adequately pretreated
- •Patient has known uncontrollable hypercoagulable condition, or refuses blood transfusion
- •Life expectancy of less than 12 months
- •Patient is currently participating in an investigational drug or another device study that may clinically interfere with the study endpoints
- •Patient has other co-morbid condition(s) that in the judgment of the physician precludes safe percutaneous intervention
- •Has end-stage renal disease defined as undergoing hemodialysis for kidney failure
- •Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
- •Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT)type II
- •Treatment of ipsilateral non-study inflow lesions with other materials than regular guidewires, regular PTA balloons, bare metal stents and/or paclitaxel-coated stents
- •Additional treatments of the study lesion requiring materials/procedures other than standard guidewires, regular PTA balloons and/or a Self-Expanding Paclitaxel-Eluting stent (e.g. thrombectomy, re-entry catheters, CTO-wires, cutting balloon, cryoballoon, etc)
结局指标
主要结局
Primary patency
时间窗: 12 months
Primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography, verified by Core Lab
次要结局
- Improvement of Rutherford classification(12 months)
- Procedural success(Procedure (day 0))
- SAE (Serious Adverse Event)(discharge, 1, 6 and 12 months)
- Limb salvage rate(Procedure, 1, 6 and 12 months)
- Primary Patency(1 and 12 months)
- Secondary patency(1, 6 and 12 months)
- Target Lesion Revascularisation(Procedure (day 0), 1, 6 and 12 months)
- Improvement in Ankle-Brachial Index(12 months)
- Technical success(procedure (day 0))
- MAE (Major Adverse Event)(1, 6 and 12 months)
研究者
研究点 (10)
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