Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon
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
- 5
- 主要终点
- Late lumen loss
研究概览
简要总结
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.
详细描述
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.
Patient population will consist of male and female adults suffering from coronary drug-eluting stent (DES) restenosis, which is to be treated by a study balloon according to the inclusion and exclusion criteria as defined below.
In Late lumen loss lesion (difference between the angiographic in-lesion MLD post procedural and at 6 months follow-up) will be evaluated by quantitative coronary angiography (QCA).
The study will be performed as a single-blind, SQP controlled study in 4 - 6 study centers in 50 patients.
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 (Participant)
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 drug-eluting stent in-stent restenosis (DES-ISR) lesions (≥ 70% diameter stenosis by visual estimation or ≥ 50% and positive functional study) including margin stenosis with max 5mm 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, vessel diameter < 2.5 mm
研究组 & 干预措施
Sirolimus coated Balloon
treatment of coronary DES-ISR with a sirolimus coated balloon
干预措施: Sirolimus coated balloon (Device)
Paclitaxel coated balloon (SeQuent Please)
treatment of coronary DES-ISR with a paclitaxel coated balloon
干预措施: Paclitaxel coated balloon (SeQuent Please) (Device)
结局指标
主要结局
Late lumen loss
时间窗: 6 months
Difference between minimal lumen diameter at follow-up coronary angiography and baseline after PCI
次要结局
- Procedural Success(24 hours)
- MACE (Major adverse cardiac events)(12 months)