CTRI/2010/091/000460招募中3 期
A Continuation of the Clinical Evaluation of the Abbott Vascular Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 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 ≥ 1.
- •If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (LAD with septal and diagonal branches, LCX with obtuse marginal and/or ramus intermedius branches and 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 greater than 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
- •Lesion(s) involving a bifurcation with side branch vessel greaterthan or equal to 2 mm in diameter and/or ostial lesion greater than 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).
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