NCT01994798Unknown不适用
Prospective, Non-randomized, Multicentre, Observational Registry to Assess Clinically Relevant Benefit of Performing the Whole PTA Procedure Using the Rapid Exchange (RX) Devices.
Terumo Europe N.V.9 个研究点 分布在 2 个国家目标入组 525 人开始时间: 2013年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 525
- 试验地点
- 9
- 主要终点
- Safety: composite of all-cause death, amputation, TVR, stroke or bleeding (BARC ≥ 3) up to 1 month
研究概览
简要总结
This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology.
详细描述
This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology
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 one or two legs ischemia, requiring treatment of SFA or popliteal artery
- •Rutherford classification 2-5
- •Single lesion with recoiling/dissection/restenosis after balloon angioplasty or de novo lesions with stenosis or occlusion,
- •Target vessel reference diameter ≥4mm and ≤7mm (by visual estimate)
- •At least one patent (less than 50% stenosis) tibioperoneal run-off vessel confirmed by baseline angiography
- •Patient is suitable candidate for femoral-popliteal artery bypass surgery
排除标准
- •Female of child-bearing potential.
- •Previous bypass surgery
- •In stent restenosis as a target lesion
- •Scheduled staged procedure of multiple lesions within the ipsilateral iliac or popliteal arteries within 30 days after index procedure.
- •Co-existing aneurysmal disease of the abdominal aorta, iliac or popliteal arteries
- •Acute thrombophlebitis or deep venous thrombosis
- •Hemodynamic instability
- •Untreated inflow disease of the ipsilateral pelvic arteries (more than 50 percent stenosis or occlusion),
- •Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
- •Known intolerance to study medications, contrast agents or nitinol.
结局指标
主要结局
Safety: composite of all-cause death, amputation, TVR, stroke or bleeding (BARC ≥ 3) up to 1 month
时间窗: From start up to 30 Days post procedure.
Total contrast media volume given during the procedure.
时间窗: During procedure
次要结局
- Total acute device related complication rate defined as any device complication up to 1 month post procedure.(Up to 30 Days post procedure)
- Technical success defined as a successful access and balloon angioplasty followed by stent placement with achieved recanalization determined by less than 30% residual stenosis by angiography at the baseline procedure.(Pre- and post-procedure)
- Clinical success defined as technically successful procedure without the events considered in safety composite endpoint (all-cause death, amputation, TVR, stroke or bleeding (BARC ≥ 3) up to 1 month.(During procedure)
- Walking distance at 30 days compared with walking distance before procedure.(30 Days post procedure)
- Bleeding complication as per BARC definitions.(Up to 30 days post procedure)
- Total duration of the procedure(During procedure)
- Total radiation dose given(During procedure)
- Total acute complication rate defined as any device- or procedure- related complication up to 1 month post procedure.(Up to 30 Days post procedure)
- Total fluoroscopy time(During procedure)
- Ankle-Brachial Index (ABI) improvement at 30 days.(30 Days post procedure)
- Improvement of the Rutherford index at 30 days.(30Days post procedure)
研究者
研究点 (9)
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