SeQuent 1000 - Treatment of Coronary Artery Disease With Bare Metal Stent Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent: Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events (MACE) - target vessel failure (TVF)
研究概览
简要总结
The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.
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
- •Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina and silent ischemia
- •Presence of one or more coronary artery stenosis >50% in a native coronary artery from 2.25 to 3.5 mm in diameter that can be covered with one stent
- •One lesion treated with the study device
排除标准
- •Pregnancy
- •Known intolerance to aspirin, clopidogrel, heparin, stainless steel, paclitaxel, cobalt, chromium or contrast material
- •Inability to provide informed consent
- •Currently participating in another trial before reaching the primary endpoint
- •Elective surgery within 12 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri-surgical period
- •Acute or recent myocardial infarction
- •left ventricular ejection fraction (LVEF) < 30 %
- •Stroke or transient ischemic attack within 6 months
- •Stented segment longer than 23 mm
- •Vessel diameter of less than 2,5 mm
- •Significant calcification, chronic total occlusion (CTO) or thrombus in the target lesion
研究组 & 干预措施
Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB)
干预措施: Coroflex Blue (BMS) followed by SeQuent Please (DEB) (Device)
Drug Eluting Stent (DES)
干预措施: Coroflex Please (DES) (Device)
结局指标
主要结局
Major adverse cardiac events (MACE) - target vessel failure (TVF)
时间窗: 9 months
consisting of the composite of cardiac death, myocardial infarction (Q-wave and Non-Q wave) localized at the territory supplied by the treated vessel or target vessel revascularization (TVR) by either percutaneous coronary intervention or bypass graft surgery in the overall population
次要结局
- In-segment percent diameter stenosis (%DS)(9 months)
- Major adverse cardiac events (MACE)(1 year)
- in-stent binary restenosis(9 months)
- In-stent and in-segment minimal luminal diameter (MLD)(9 months)
- Angiographic and clinical stent thrombosis(3 years)
- In-stent and in-segment late luminal loss(9 months)
- Angiographic and clinical stent thrombosis(1 year)
- Angiographic and clinical stent thrombosis(30 days)
- Angiographic and clinical stent thrombosis(6 months)
- Angiographic and clinical stent thrombosis(9 months)
- Angiographic and clinical stent thrombosis(2 years)