CTRI/2010/091/000460招募中Phase 3 4
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
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 8
- 主要终点
- This trial has no primary outcome, all outcomes are of equal weight) Acute success (clinical device and clinical procedure)
研究概览
简要总结
ABSORB EXTEND Clinical Investigation: This trial is a continuation in the Clinical Evaluation of the Abbott Vascular Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions. The Primary Investigator and study Chair for this study are: Alexandre Abizaid, MD Study Principal Investigator Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia. Brazil Patrick Serruys, MD Study Chair Thoraxcenter-Erasmus University Netherlands This is a global trial and began international recruitment in January of 2010. Recruitment in India has not yet begun. Recruitment of 1000 participants worldwide is expected. Approximately 105 patients overall will be enrolled in India, equating to approximately 15 patients at each site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
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 ≥
- •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
- •â€¢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.
- •â€¢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.
- •â€¢Total occlusion (TIMI flow 0), prior to wire passing.
- •â€¢Target vessel(s) contains visible thrombus.
- •â€¢Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).
- •â€¢Subject has received brachytherapy in any epicardial vessel (including side branches).
结局指标
主要结局
This trial has no primary outcome, all outcomes are of equal weight) Acute success (clinical device and clinical procedure)
时间窗: Acute
次要结局
- Cardiac Death (CD)(30, 180 days, and 1, 2, and 3 years.)
- Ischemia Driven MACE (ID MACE)(30, 180 days, and 1, 2, and 3 years)
- Ischemia Driven Target Vessel Revascularization (ID TVR)(30, 180 days and 1, 2, and 3 years)
- OCT: Descriptive analysis of strut, lesion and vessel morphology post-procedure(2 years)
- Target Vessel Myocardial Infarction (TV-MI)(30, 180 days, and 1, 2, and 3 years)
- OCT: Incomplete apposition (baseline), persisting incomplete apposition, late incomplete apposition(2 years (if analyzable))
- Angiographic OCT subgroup: Treated site Late Loss (LL)(2 years)
- Angiographic OCT subgroup: Proximal LL (proximal defined as within 5 mm of tissue proximal to scaffold placement)(2 years)
- Angiographic OCT subgroup: Treated site and treated segment Angiographic Binary Restenosis (ABR) rate(2 years)
- Angiographic OCT subgroup: Aneurysm, thrombus, persisting dissection(2 years)
- IVUS OCT subgroup: Minimum luminal area (MLA)(post-procedure and at 2 years)
- IVUS OCT subgroup: Treated site %Volume Obstruction (VO)(2 years)
- OCT: Scaffold area post-procedure (if analyzable)(2 years)
- Angiographic OCT subgroup: Treated site and treated segment Minimum Luminal Diameter (MLD)(post-procedure and at 2 years)
- Ischemia Driven Target Lesion Revascularization (ID TLR)(30, 180 days and 1, 2, and 3 years)
- Myocardial Infarction (MI)(30, 180 days, and 1, 2, and 3 years)
- Scaffold thrombosis(30, 180 days, and 1, 2, and 3 years)
- OCT: Lumen area(post-procedure and at 2 years)
- OCT: Minimum luminal area (MLA)(post-procedure and at 2 years)
- Angiographic OCT subgroup: Treated segment LL(2 years)
- Angiographic OCT subgroup: Distal LL (distal defined as within 5 mm of tissue distal to scaffold placement)(2 years)
- Ischemia driven Target Vessel Failure (ID TVF)(30, 180 days, and 1, 2, and 3 years)
- Angiographic OCT subgroup: Treated site and treated segment % Diameter Stenosis (DS)(post-procedure and at 2 years)
- MSCT subgroup: Descriptive analysis of vascular and scaffold morphology(18 months)
- IVUS OCT subgroup: Vessel area(post-procedure and at 2 years)
- IVUS OCT subgroup: Scaffold area (if analyzable)(post-procedure and 2 years)
- IVUS OCT subgroup: Incomplete apposition (baseline), persisting incomplete apposition, late incomplete apposition(2 years (if analyzable))
- Ischemia driven Non-Target Vessel Revascularization (ID non- TVR)(30, 180 days and 1, 2, and 3 years)
- Lumen area(post-procedure and at 2 years)
研究者
研究点 (8)
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