Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated SEQUENT® SCB RAPID EXCHANGE PTCA Balloon Catheter or a Paclitaxel Coated SEQUENT® PLEASE PTCA Balloon Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- InnoRa GmbH
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- late lumen loss in-lesion at 6 months
研究概览
简要总结
Treatment of coronary in-stent restenosis (ISR) by a sirolimus coated SEQUENT® SCB RAPID EXCHANGE PTCA balloon catheter or a paclitaxel coated SEQUENT® PLEASE PTCA balloon catheter
详细描述
Experimental intervention: Predilatation of coronary ISR with POBA followed by a sirolimus coated SeQuent®SCB balloon balloon (sirolimus 4.0 μg/mm²)
Control intervention: Predilatation of coronary ISR with POBA followed by a paclitaxel coated SeQuent®Please balloon or SeQuent®Please NEO balloon (paclitaxel 3.0 μg/mm²)
Duration of intervention per patient: minutes
Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months clinical follow up
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
- Single (Outcomes Assessor)
盲法说明
Blinded QCA for primary outcome
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
- •18 years of age
- •Clinical evidence of stable or unstable angina (acute coronary syndrome) or a positive functional study
- •Patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis by visual estimation or ≥50% and positive functional study) including margin-stenosis with max 5 mm distance to the stent
排除标准
- •Chronic renal insufficiency with serum creatinine levels > 2.0 mg per deciliter
- •Known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or sirolimus, and sensitivity to contrast media not amenable to premedication
- •Concomitant medical illness associated with a life-expectancy of less than two year
- •Lesion length (ISR) > 35 mm, reference vessel diameter < 2.5 mm
结局指标
主要结局
late lumen loss in-lesion at 6 months
时间窗: 6 months
late lumen loss in-lesion at 6 months assessed by blinded QCA
次要结局
- MACE(6 and 12 months)
- Procedural Success(during hospital stay of index procedure)
- Individual clinical endpoints(6 and 12 months)