NCT01023789已完成不适用
ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold (BVS) System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 812
- 试验地点
- 92
- 主要终点
- Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
研究概览
简要总结
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System
ABSORB BVS is currently in development at Abbott Vascular.
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
- •Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.
- •Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is ≥ 2.0 mm and ≤ 3.3 mm and target lesion length is ≤ 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).
- •Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥
- •If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (LAD with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).
- •Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥ 30 days prior to or if planned to be done 6 months after the index procedure.
- •Percutaneous intervention for lesions in the target vessel are allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure.
排除标准
- •Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
- •Lesion(s) involving a bifurcation with side branch vessel ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation.
- •Total occlusion (TIMI flow 0), prior to wire passing.
- •Target vessel(s) contains visible thrombus.
- •Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).
- •Subject has received brachytherapy in any epicardial vessel (including side branches).
研究组 & 干预措施
ABSORB BVS
Experimental
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
干预措施: ABSORB BVS (Device)
结局指标
主要结局
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
时间窗: 0 to 1 year
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
次要结局
- Mean Reference Area(18 months)
- Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)(0 to 3 years)
- Minimum Vessel Area(18 months)
- Maximum Lumen Area(18 months)
- Maximum Plaque Area(18 months)
- Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)(0 to 3 years)
- Mean Lumen Area(18 months)
- Minimum Plaque Area(18 months)
- Number of Participants With Cardiac Death(0 to 3 years)
- Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)(0 to 3 years)
- Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)(0 to 3 years)
- Maximum Vessel Area(18 months)
- Clinical Device Success(On day 0 (immediate post-index procedure))
- Clinical Procedure Success(On day 0 (immediate post-index procedure))
- Number of Participants With Scaffold Thrombosis (Early)(0 to 30 days)
- Number of Participants With Scaffold Thrombosis (Late)(31 - 365 days)
- Number of Participants With Scaffold Thrombosis (Very Late)(366 days to 2 years)
- Area Stenosis (%)(18 months)
- Minimum Lumen Area(18 months)
- Mean Vessel Area(18 months)
- Mean Plaque Area(18 months)
- Number of Participants With Myocardial Infarction (MI) - Per Protocol(0 to 3 years)
- Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)(0 to 3 years)
- Number of Participants With Scaffold Thrombosis(0 to 3 years)
- Calculated Minimum Lumen Diameter(18 months)
- Calculated Diameter Stenosis(18 months)
研究者
研究点 (92)
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