A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With de Novo Native Coronary Artery Lesions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 14
- 主要终点
- Hierarchical Major Adverse Cardiac Event (MACE)
研究概览
简要总结
The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels.
Currently in development at Abbott Vascular. Not available for sale in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Absorb stent
Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)
干预措施: Bioabsorbable Everolimus Eluting Coronary Stent (Device)
结局指标
主要结局
Hierarchical Major Adverse Cardiac Event (MACE)
时间窗: 1 year
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days
时间窗: 180 days
In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year
时间窗: 1 year
In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up
次要结局
- In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years(2 years)
- In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years(3 years)
- Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years(2 years)
- Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years(3 years)
- In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years(5 years)
- Clinical Device Success (Per Lesion)(On day 0 (the day of procedure))
- Clinical Procedure Success (Per Patient)(On day 0 (the day of procedure))
- Hierarchical Target Vessel Failure (TVF)(5 years)
- Hierarchical Major Adverse Cardiac Event (MACE)(5 years)
- Cardiac Death(5 years)
- Myocardial Infarction(5 years)
- Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year(1 year)
- Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years(2 years)
- Persisting Dissection(5 years)
- Volume Obstruction (VO)(3 year)
- Ischemia Driven Target Lesion Revascularization (ID-TLR)(5 years)
- Ischemia Driven Target Vessel Revascularization (ID-TVR)(5 years)
- Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days(180 days)
- Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year(1 year)
- Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days(180 days)
- Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years(3 years)
- Aneurysm(5 years)
- Late Incomplete Apposition(3 year)
- Scaffold Thrombosis(5 years)
- Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years(5 years)
- In-scaffold Percent Diameter Stenosis (%DS)(5 years)
- Persisting Incomplete Apposition(3 year)
- Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years(5 years)
- Vasomotion Analysis: In-scaffold Mean Luminal Diameter(5 years)
- In-scaffold Angiographic Binary Restenosis (ABR)(5 years)
- Thrombus(5 years)