Luminor Registry: Registry of the Results of Angioplasty With Drug-eluting Balloon (Paclitaxel) in the Treatment of Infrainguinal Occlusive Lesions (Superficial Femoral Artery (SFA), Popliteal Artery (PA) and Tibial Arteries (ATs)) and Restenosis From Prior Endovascular Procedures in This Sector.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Primary patency
研究概览
简要总结
The purpose of the study is to obtain data regarding safety and efficacy of drug-eluting balloon luminor 14 & luminor 35 in the treatment of infrainguinal occlusive lesions (superficial femoral artery (SFA), popliteal artery (PA) and tibial arteries (ATs)) and restenosis from prior endovascular procedures in this sector.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 of both sexes aged at least 18
- •Primary injuries and restenosis of the infrainguinal sector of AFS, AP and ATs, and intrastent restenosis or post-ATP prior in that sector.
- •Stenosis >50% and occlusions. (image test)
- •Length: 20 to 200 mm
- •Artery diameter: 2-7 mm.
- •Symptomatic patients (grades 2-5 Rutherford-Baker both included; Fontaine II-IV), affected in their quality of life and that accept treatment (moderate / severe claudication patients, critical ischemia without gangrene or injuries severe enough to foresee limb amputation).
排除标准
- •Patients with acute or subacute ischemia will be excluded.
- •Existence of flow-limiting lesions in arteries of the "in flow" or the "out flow" of the sector or artery under treatment (> 50 % of the arterial diameter).
- •Aneurysmal dilatation in the ipsilateral arterial axis.
- •Intolerance / allergy to heparin, thienopyridine derivatives (clopidogrel , ticlopidine) and aspirin.
- •Hemorrhagic diathesis during the 3 months prior to inclusion.
- •Patients with a life expectancy of less than 12 months.
- •Serious allergy to contrasts or PTX.
- •Inability to cross the lesion with the guide (these cases will be recorded for the analysis as "intention to treat).
- •Those participating simultaneously in another clinical trial.
- •Pregnancy or lactation (pregnancy tests on fertiles).
结局指标
主要结局
Primary patency
时间窗: 1 year
Primary patency (performance target) of the angioplasty (PTA) performed with drug eluting balloons (DEB) in stenotic/occlusive primary lesions, in restenosis of the AFS, AP and ATs, or in stents from previous procedures in these arteries, with follow-up of 12 months.
Freedom of adverse events
时间窗: 1 year
Freedom of adverse effects (AE). EA are considered in combination: death, amputation and the need for revascularization of the target lesion (safety objective).
次要结局
未报告次要终点