NCT01651390已完成不适用
BIOLUX RCT - Clinical Performance of the Pantera LUX Paclitaxel Releasing Balloon Versus the Drug Eluting Orsiro Hybrid Stent System in Patients With In-stent Restenosis - a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biotronik AG
- 入组人数
- 231
- 试验地点
- 28
- 主要终点
- Late lumen loss (in-stent)
研究概览
简要总结
To determine in a randomized controlled trial (RCT) whether percutaneous coronary intervention - in patients with in-stent restenosis in either bare metal stents or drug eluting stents - with the Pantera Lux balloon is angiographically non-inferior to percutaneous intervention with the Orsiro stent 6 months post-procedure.
详细描述
This clinical investigation is an international, multi-center, randomized controlled trial with angiographic follow up at 6 months. Clinical follow ups will take place at 6, 12 and 18 months.
Up to 210 subjects will be block randomized 2:1 to receive the Pantera Lux balloon or the Orsiro stent and will be stratified according to diabetic status at screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject has provided a written informed consent
- •Subject ≥ 18 years
- •Clinical evidence of ischemic heart disease and/or a positive functional study, stable or unstable angina pectoris or documented silent ischemia
- •Subject eligible for percutaneous coronary intervention
- •Subject acceptable candidate for coronary artery bypass surgery
- •Subject with an in-stent restenotic lesion* in either a bare metal stent or drug eluting stents (Mehran class I, II, III, IV - Mehran et al. Circulation 199; 100: 1872-1878). *Target lesion
- •Subjects with a maximum of 2 target lesions. In case of 2 target lesions, both lesions must be either in bare metal stents or drug eluting stents, and must treated during the same session with the same type of device as per randomization outcome, e.g. drug eluting stent.
- •Target reference vessel diameter (visual estimation): ≥ 2.0 and ≤ 4.0 mm
- •Target lesion length (visual estimation): ≥ 6.0 and ≤ 28.0 mm
- •Target lesion stenosis (visual estimation): > 50 % and ≤ 100 %
- •Target lesion in a native coronary artery
排除标准
- •Planned (staged) interventional treatment in the same vessel(s) as the target lesion(s) within 30 days pre- and/or post BIOLUX RCT index procedure.
- •Evidence of acute ST-segment-elevation myocardial infarction within 48 hours prior to index procedure according to the universal definition of myocardial infarction
- •Subjects with acute cardiac decompensation or acute cardiogenic shock
- •Subject with a life expectancy of less than 18 month
- •In the investigators opinion subject who will not be able to comply with the follow up requirements
- •Impaired renal function (excluded are subjects in need of dialysis or subjects with a creatinine level ≥ 221 µmol per liter (2.5 mg per deciliter) within 72 hours of the intended treatment)
- •Thrombus in the target vessel
- •Target lesion located in left main coronary artery
- •Documented left ventricular ejection fraction (LVEF) ≤ 30%
- •Known allergies to: acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparin, contrast medium, sirolimus or similar drugs (i.e., ABT 578, biolimus, tacrolimus); CoCr, PLLA, silicon carbide
- •Subject is receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
- •Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached
- •Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study
- •Previously enrolled in this trial
结局指标
主要结局
Late lumen loss (in-stent)
时间窗: After 6 months.
In-stent late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA). In-stent: Pantera Lux balloon: In-stent is defined as from (proximal) shoulder to (distal) shoulder of the dilated balloon. Orsiro stent: In-stent is defined as from (proximal) edge to (distal) edge of the implanted Orsiro stent.
次要结局
- Binary restenosis in-stent and in-segment(After 6 months.)
- Mean lumen diameter in-stent and in-segment(After 6 months.)
- Percent diameter stenosis in-stent and in-segment(After 6 months.)
- Device success(1 day (During procedure))
- Type of reoccurrence according to Mehran classification(After 6, 12 and 18 months.)
- Target lesion failure (TLF)(After 6 and 18 months.)
- Target vessel failure (TVF)(After 6, 12 and 18 months.)
- Procedure success(During hospital stay or 7 days after procedure, whichever came first.)
- Stent thrombosis(After 6, 12 and 18 months.)
研究者
研究点 (28)
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