NCT01783600已完成4 期
NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- primary Patency
研究概览
简要总结
The objective of this clinical evaluation is to evaluate the immediate and long-term (up to 12 months) outcome of NanoCrossTM balloon catheter (Covidien) in a prospective, non-randomised, controlled investigation for the treatment of patients with critical limb ischemia (Rutherford 4-5) due to the presence of lesions of minimally 10cm in length at the level of the below-the-knee arteries.
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 99 Years（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 class 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 the NanoCrossTM .014 balloon catheter (Covidien)
- •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 or restenotic lesion after PTA in the infrapopliteal arteries,suitable for endovascular therapy
- •Total target lesion length minimally 100mm
- •Target vessel diameter visually estimated to be >1.5mm and <4.0mm
- •Guidewire and delivery system successfully traversed lesion
- •At least one non-occluded crural artery with angiographically documented run- off to the foot.
排除标准
- •Patient refusing treatment
- •The reference segment diameter is not suitable for the available balloon design
- •Untreated flow-limiting inflow lesions
- •Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
- •Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
- •Aneurysm in the target vessel
- •Target lesion has severe calcification as determined by physician's discretion
- •Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
- •Severe medical comorbidities (untreated CAD/CHF, severe 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
- •Any previously known coagulation disorder, including hypercoagulability
- •Contraindication to anticoagulation or antiplatelet therapy
- •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
- •Currently participating in another clinical research trial
- •Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
- •Target lesion access not performed by transfemoral approach.
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 duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the 12-month follow-up
次要结局
- Technical success(Day 0 (=procedure date))
- Secondary patency rate(1, 6, 12-month follow-up)
- Clinical success at follow-up(1 day and 1, 6, 12-month follow-up)
- Primary assisted patency rate(1, 6, 12-month follow-up)
- Number of patients with Serious Adverse Events (SAE) as a measure of safety(1 day, 1 month, 6 month and 12 month follow-up)
- Hemodynamic primary patency(1 and 6 months follow-up)
- Limb-salvage rate(1, 6 and 12 months follow-up)
- Target lesion revascularization(1 day, 1 month, 6 month and 12 month follow-up)
研究者
研究点 (8)
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