NCT01420120已完成不适用
A Prospective Multicenter Registry to Evaluate Safety and Performance of REMEDY, Biodegradable Peripheral Stent for the Treatment of Occluded or Stenotic Superficial Femoral Arteries.
be Medical1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Absence of clinically driven target lesion revascularization at 12 months.
研究概览
简要总结
This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries. Patients will be followed for a period of 1 year.
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
- •Patients with symptomatic leg ischemia requiring treatment of SFA artery or proximal popliteal artery located within the following parameters:
- •1 cm from the femoral bifurcation in the SFA
- •3 cm from the proximal margin of the intercondylar fossa
- •Rutherford-Becker Category 2-
- •In patients with bilateral lesions, the highest Rutherford Category limb should be treated. Only 1 leg can be included.
- •Single lesion which can be covered by one stent.
- •Target vessel reference diameter ≥ 4 mm and ≤ 6 mm (by visual estimate)
- •A patent popliteal artery free from significant stenosis (>50%) with at least one patent vessel runoff as confirmed by baseline angiography
- •Signed informed consent.
排除标准
- •Pregnancy
- •Previous stenting of target lesion
- •Acute ischemia
- •Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion). Inclusion of a patient is allowed in case inflow lesions are successfully treated during the index-procedure yielding less than 30% diameter stenosis.
- •Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
- •Known intolerance to study medications or contrast agents.
结局指标
主要结局
Absence of clinically driven target lesion revascularization at 12 months.
时间窗: 12 months
次要结局
- Primary and secondary patency rate(12 months)
- Ankle-Brachial Index improvement of ≥ 0.1(1, 6 and 12 months)
- Clinically driven target vessel revascularization(6 and 12 months)
- Technical success(During procedure)
- Clinical success(During procedure)
- Major complications at 6 and 12 months, including amputation of a part of the foot, the leg below and above the knee.(6 and 12 months)
- Rutherford-Becker classification of chronic limb ischemia(1, 6 and 12 months)
研究者
研究点 (1)
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