Acrobat Coronary Stent System Effectiveness European Study (European Multicenter Effectiveness Randomized Study of Svelte Medical Systems Acrobat Stent on a Wire Compared to Other BMS PCI in de Novo Coronary Lesions) ACES Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 300
- 试验地点
- 24
- 主要终点
- Proportion of patients free of Major Adverse Cardiac Event ("MACE-free patients")
研究概览
简要总结
The purpose of this randomized controlled trial (RCT) is to demonstrate the clinical benefit and impact on resource utilization of percutaneous coronary interventions (PCI) with the Svelte Acrobat Stent System compared to any other CE marked bare metal stent (BMS) implantable via direct stenting or after lesion pre-dilation, in patients with coronary lesions that are eligible for direct stenting and who are recruited and treated so as to reflect real-life routine practice.
详细描述
The main objectives of this study are to test the following hypotheses:
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The evaluated stent is clinically non-inferior to control BMS in terms of freedom of MACE
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The evaluated stent is clinically beneficial compared to control BMS by reducing exposure to radiations, amount of contrast medium administered, procedure time, as well as amount of administered heparin,
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The evaluated stent does not result in more frequent adverse events than control BMS,
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The evaluated stent improves direct stenting success while not decreasing procedural success compared to control BMS.
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Resource utilization (R.U.):
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Hospital-perspective resource utilization during the index admission and index procedure is not greater with evaluated the stent and potentially lower than with control BMS
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Resource utilization over a 6-month time-horizon, in relation to routine follow-up and MACE, is not greater with the evaluated stent than with control BMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Eligible for PCI and demonstrating native vessel or vein/arterial graft disease
- •symptomatic CAD: either stable angina pectoris (CCS 1, 2, 3 pr 4) or unstable (Braunwald Class 1-3, B-C) or positive functional ischemia study
- •Male and post-menopausal female
- •Patient provides written informed consent prior to procedure
- •Patient willing to comply with protocol
- •Acceptable candidate for CABG
- •Patient indicated for stenting of one or more de novo stenotic lesions in native coronary arteries or bypass grafts with or without direct stenting
- •All target lesions for stenting in single or multi-vessel disease meet all inclusion criteria
- •None of the lesions requires stenting with Drug eluting stents
- •At least one lesion is visually estimated to be candidate for direct stenting
- •All target lesions for stenting have a visually estimatd RVD >= 2.5 mm and <= 3.5 mm
- •All target lesions for stenting are visually estimated to have LL =< 20 mm (to cover the lesion with 1 stent)
- •All target lesions for stenting visually estimated to have a stenosis > 50% and < 99%
- •All target lesions for stenting are ACS lesions TIMI flow >= 1
排除标准
- •Currently enrolled in another clinical trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- •A previous coronary procedure within 30 days
- •Any of the target lesion(s) requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
- •Previous BMS deployment anywhere in the target vessel within the past 6 months
- •Any DES deployment anywhere in the target vessel within the past 9 months
- •Any previous stent placement within 10 mm (proximal or distal) of the target lesion
- •Patient has diabetes mellitus
- •Co-morbid condition(s) that could limit the patient's participation or impact the trial
- •Documented LVEF < 30% at the most recent evaluation
- •Evidence of AMI within 72 hours of the intended trial procedure and/or with TIMI flow 0
- •History of CVA or TIA in the last 6 months
- •Leukopenia (<3.5 x 10^9/L)
- •Neutropenia (<1000/mm3) <= 3 days prior to enrollment
- •Thrombocytopenia (<10^5/mm3) pre-procedure
- •Active peptic ulcer or active GI bleeding
- •History of bleeding diathesis or coagulopathy or inability to accept blood transfusions
- •Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated
- •Serum creatinine level > 2.5 mg per dl within 7 days prior to index procedure
- •In-stent restenosis
- •Patient not able to give consent or read or write or protected by law or under guardianship or deprived of civil rights
- •Woman of childbearing age
- •Patient not covered by health or social insurance
- •Unprotected left main CAD with obstruction > 50% , not protected by at least one non-obstructed bypass graft to the LAD or left circumflex (LCX) artery or their branches
- •Target vessel exhibiting multiple lesions > 40% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion(s) to be stented based on visual estimate or on-line QCA
- •Any target lesion for stenting exhibits an intraluminal thrombus (occupying > 50% of the true lumen diameter) at any time
- •Any target lesion for stenting is excessively tortuous (two bends > 90° to reach the target lesion)
- •Lesion location that is aorto-ostial or within 5 mm of the origin of the LAD or LCX
- •Any target lesion for stenting is has side branches > 2.0 mm in diameter in which bifurcation stenting is planned
- •Any target lesion >20 mm
- •Any target lesion totally occluded (CTO)
- •Any target lesion has TIMI flow = 0
- •Any target lesion with ISR
结局指标
主要结局
Proportion of patients free of Major Adverse Cardiac Event ("MACE-free patients")
时间窗: From the date and time of randomization until 6 months after the index procedure
Major Adverse Cardiac Event ("MACE") is defined here as device-oriented composite endpoint that includes, in hierarchical order: Cardiac death (All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established), Myocardial Infarction ("MI"), Target Lesion Revascularization ("TLR").
次要结局
- administered dye(intra-procedural)
- radiation exposure(intra-procedural)
- procedure duration(intra-procedural)
- acute success(procedure to discharge)
- heparin administration(intra-procedural)
- adverse events(6 months)