NCT03346577终止不适用
Endovascular Treatment of Peripheral Artery Disease
be Medical1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年5月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Binary restenosis
研究概览
简要总结
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 must sign the informed consent form prior to the index-procedure.
- •Patient is older than 18 years.
- •Patient is compliant with the requested follow-up visits at week 6 and month 12 and the treatment regime.
- •Patient suffers from intermittent claudication (Rutherford 2-3) or critical limb ischemia (Rutherford 4-5).
- •Target lesion is an occlusion or diameter stenosis is ≥70% by visual estimate.
- •Target lesion is located in the common and external iliac artery, in the common and superficial femoral artery, popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery) .
排除标准
- •Patients with Rutherford 0, 1 and
- •Patient is pregnant.
- •Patients with serum creatinine >2.0 mg/dL or renal dialysis.
- •Patient has an acute thrombus or aneurysm in the target arteries.
- •Patient has a life expectancy of <12 months.
- •Patient with bypass that involves the target arteries.
- •Patient has a target lesion that cannot be crossed with a guidewire.
- •Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
- •Patient has scheduled elective non-vascular procedures within 3 months after index-procedure. Vascular procedures are allowed within 3 months after the index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted.
- •Contraindication for anti-thrombotic therapy (coagulopathy, ...).
- •Patient has a known intolerance to anti-thrombotic medication or contrast agents.
结局指标
主要结局
Binary restenosis
时间窗: at 12 months follow-up
Binary restenosis defined as ≥ 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio \>2.4)
次要结局
- Immediate procedural outcome(up to 12 months follow-up)
- Device-related complications(up to 12 months follow-up)
- Clinical outcome(at 12 months follow-up)
- Primary sustained clinical improvement(at 12 months follow-up)
- Secondary sustained clinical improvement(at 12 months follow-up)
- Mortality(up to 12 months follow-up)
- Amputation(up to 12 months follow-up)
- Stent fracture(up to 12 months follow-up)
- Target lesion revascularization (TLR)(up to 12 months follow-up)
研究者
研究点 (1)
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