A French, Multicentric, Randomized, Simple Blind, Superiority Study Comparing the Efficiency and the Safety at 24 Months of the Stent Titan2 Versus Bare Metal Stent in Cobalt-Chrome in All Comers Patients Among Which 40 % Present an ACS.
试验速览
- 阶段
- 4 期
- 入组人数
- 1,350
- 试验地点
- 42
- 主要终点
- MACE
研究概览
简要总结
The purpose of this study is to compare the effectiveness and safety, at 24 months, of the TITAN2 stent to any bare-metal stent (BMS) in Cobalt-Chromium in a population presenting an indication for these stents among 40% of which present an acute coronary syndrome (ACS).
详细描述
The EVIDENCE II trial is a post-registration study for TITAN2 stent initiated on the request of the French Health Authorities' (HAS) in June 2009 for the next renewal of registration on the list of reimbursable products and services in France.
The study is so designed to compare the effectiveness and safety at 24 months of the TiTAN2 versus Cobalt-Chromium BMS randomly assigned. As a part of the secondary objectives, a cost-effectiveness study is also planned.
The comparators are cobalt chromium stents CE marketed and free of any coating (nude BMS).
All will be used in their authorized indications.
A total of 1350 patients will be included over a period of a year or more and followed for 24 months for the primary endpoint (MACE rate at 24 months in the overall population : cumulative incidence of cardiac deaths, MI and target lesion revascularization (TLR)).
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
- Single (Participant)
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
- •Patient with symptomatic de novo coronary lesion involving one or two vessels
- •Patient presenting a lesion with > 50% stenosis
- •Patient who must undergo a percutaneous coronary intervention (PCI) in the indications of Cobalt-chromium bare metal stents and TITAN2 stents and being able to be indifferently treated with one or the other of these stents.
- •Written informed consent
- •Expected survival > 2 years
- •Patient reachable by phone throughout the duration of the study.
排除标准
- •Pregnant/Lactating women
- •Women of childbearing potential (last menstrual period <12 months) not using effective contraception
- •Patient under legal protection
- •Indication of coronary artery bypass graft surgery (CABG)
- •History of coronary artery bypass graft surgery (CABG)
- •Intrastent restenosis lesion
- •Bifurcation lesion with the exception of those treated with a standardized approach (provisional stenting with final kissing in the side branch)
- •Left main coronary lesion
- •Ostial target lesion
- •Previous drug-eluting stenting
- •Previous bare metal stenting or balloon angioplasty in the 12 months prior the inclusion; if this implantation involved the target artery, separate the new implanted stent at a distance ≥ 10 mm.
- •History of stent thrombosis
- •Heavily calcified lesion
- •Use of the Rotablator
- •Left ventricular ejection fraction (LVEF) < 30%
- •Cardiac arrest, cardiogenic shock or severe heart failure (Killip stage III or IV)
- •Severe chronic renal failure (creatinine clearance <30 ml min)
- •Cardiac or renal transplantation
- •Major surgery within the last 14 days
- •Surgery scheduled within 30 days (non-ACS patients) or 12 months (if ACS) at the time of the randomization
- •History of major bleeding
- •Pathology with major risk of bleeding or any condition, allergy or intolerance which is incompatible with anticoagulation and / or extended antiplatelet therapy
- •Known allergy to Titanium, Nickel, Cobalt or Chromium
- •Patient currently participating in another clinical trial
- •Non-compliant patient (treatment and follow-up)
- •Patient living abroad
结局指标
主要结局
MACE
时间窗: 24 months
The primary endpoint (MACE) is the composite of cardiac death, (Myocardial Infarction) MI and target lesion revascularization (TLR). These events will be collected post-procedure during the patient's hospitalization and at 6 , 12 and 24 month follow-up.
次要结局
- Medico economic evaluation(24 months)
- Target Lesion Revascularization (TLR ) rate(24 months)
- Stent thrombosis rate(24 months)
- Success of the procedure(24 months)