Postmarketing Surveillance Registry to Monitor Everolimus-eluting Bioresorbable Vascular Scaffold Following Rotational Atherectomy for the Treatment of Complex Coronary Lesions - The ASSURE ROT Registry
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- 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 following rotational atherectomy in patients with complex 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
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
- Acute procedural success(At the end of hospital stay (maximum of 7 days))
- Acute device success(At time of intervention)
- Myocardial infarction(At time of intervention, and at 6, 12, 24, and 36 months)
- Cardiac death(At time of intervention, and at 6, 12,24, and 36 months)
- Ischemia driven target lesion revascularisation (TLR)(At time of intervention, participants will be followed for the duration of hospital stay (an expected average of 3 days), at 6, 12, 24, and 36 months)
- In-lesion % diameter stenosis(Baseline and final at time of intervention and at 24 months FU)
- Minimal lumen diameter (MLD)(Baseline and final at time of intervention and at 24 months FU)
- In-scaffold late lumen loss (LLL)(At 24 months FU)
- Scaffold thrombosis(At time of intervention, and at 6, 12, 24, and 36 months)
- Ischemia driven target vessel revascularisation (TVR)(at 6, 12, 24, and 36 month)