ABSORB: Initial Clinical Experience With the Everolimus-eluting Bioresorbable Vascular Scaffold (BVS) System in the Treatment of de Novo Native Coronary Artery Lesions - a Surveillance Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 试验地点
- 6
- 主要终点
- (This trial has no primary outcome, all outcomes are of equal weight), Major Adverse Cardiac Event (MACE)
研究概览
简要总结
The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting bioresorbable vascular scaffold (BVS) system in patients with de novo native coronary artery lesions in all-day clinical practice.
详细描述
Bioresorbable scaffolds are transient implants. They act like drug-eluting metallic stents (DES) during the first 3 months by supporting the vessel wall thereby keeping the artery patent. Subsequently, resorption of the scaffold begins and its structure loosens. As a result of everolimus release, neointimal growth is inhibited similar to DES. Finally the implant is reabsorbed completely in about 2-3 years. BVS in terms of late stent thrombosis may be safer than DES. Transiently scaffolded vessels may regain their natural curvature and angulation as well as response to nitroglycerine and endothelial function.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
(This trial has no primary outcome, all outcomes are of equal weight), Major Adverse Cardiac Event (MACE)
时间窗: at 24 months
Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardiac death
次要结局
- In-lesion late lumen loss(At angiographic follow-up if applicable)
- In-scaffold % diameter stenosis(At time of intervention and at angiographic FU if applicable)
- Minimal lumen diameter (MLD)(Prior and post procedure and at FU if applicable)
- Proximal and distal late lumen loss (LLL)(At angiographic follow-up if applicable)
- Cardiac death(At time of intervention, and at 6, 12,24, 36 months)
- In-scaffold late lumen loss (LLL)(At angiographic follow-up if applicable)
- Scaffold thrombosis(At time of intervention, and at 6, 12, 24, 36 months)
- Myocardial infarction(At time of intervention, and at 6, 12, 24 36 months)
- Ischemia driven target lesion revascularisation (TLR)(At time of intervention, and at 6, 12, 24, 36 months)
- Response to nitroglycerin(Before scaffold implantation, during angiographic follow-up if applicable)
- Curvature (cm-1)(Prior and post procedure and at angiographic follow-up if applicable)
- Angulation (°)(Prior and post procedure and at angiographic follow-up if applicable)
- Clinical success(At time of intervention, and at 6, 12, 24, 36 months)
- Acute procedural success(At the end of hospital stay (maximum of 7 days))
- Acute device success(At time of intervention)
- In-lesion angiographic binary restenosis (≥ 50%)(At angiographic follow-up if applicable)
- Major Adverse Cardiac Event (MACE)(At time of intervention, participants will be followed for the duration of hospital stay (an expected average of 3 days), at 6, 12, 36 months)
- Ischemia driven target vessel revascularisation (TVR)(at 6, 12, 24, 36 months)
- Ischemia driven target vessel failure (TVF)(at 6, 12, 24, 36 month)
- In-lesion % diameter stenosis(Prior procedure)
- Coronary artery bypass grafting (CABG)(at 6, 12, 24, 36 month)
研究者
Detlef Mathey
Professor Dr. med. D. Mathey
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.