TITANIC-XV Trial: Prospective, Multicenter and Randomized Trial (Bioactive Bare Metal Titanium Stent Versus Everolimus Drug Eluting Stent)
试验速览
- 阶段
- 4 期
- 试验地点
- 16
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
Even though the safety of drug eluting stents has been long established, in roughly 25% o patients their implantation is not considered, for specifically clinical reasons (chronic anticoagulation, bleeding, etc...), which make prolonged use of clopidogrel unsuitable. A considerable percentage of these patients have diabetes mellitus, a well known risk factor for stent thrombosis. Recently, the special characteristics of the titanium stent with nitric oxide have been described, causing it to be considered as a bioactive stent.
The TITANIC-XV trial was a prospective randomized multi-center active-treatment-controlled clinical trial, with the chief aim to evaluate clinical outcome after titanium bare metal stent (Titan2®, Hexacath, Paris, France) implantation as compared with everolimus drug eluting stent (Xience-V®, Abbott Vascular, Santa Clara, California, USA) in diabetic patients undergoing percutaneous coronary intervention.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Diabetes mellitus according to the World Health Organization Report
- •Percutaneous coronary intervention due to at least one significant de novo lesion (defined as at least 50% diameter stenosis by visual estimation) in a native coronary artery or coronary bypass graft.
- •Informed Consent "signed"
排除标准
- •Inclusion in another clinical research protocol
- •Pregnancy
- •STEMI within 48 hours
- •Unprotected left main disease
- •Restenotic lesions
- •Stent diameter < 2,5 mm or > 3,5 mm
- •Stent length more than 28 mm in < 3 mm vessels
- •Chronic total occlusions
- •Allergy to aspirin, clopidogrel, heparin or abciximab
- •Active bleeding or a significant increase in bleeding risk
- •Significant renal insufficiency defined as creatinine > 2 mg/dl
- •Severely depressed LV function (EF≤35%)
- •Cardiogenic shock
- •Ischemic stroke within the last 6 months
- •Contraindication for DES
- •Disease with life expectancy < 12 months
结局指标
主要结局
Major adverse cardiac events
Comparison of major adverse cardiac events defined as death, non fatal myocardial infarction, brain stroke or new revascularization at 1, 6, 12 and 24 months follow-up between the two treatment strategies.
次要结局
- Late luminal loss
研究者
Jose Ramon Lopez Minguez
MD, PhD, Chief of Interventional Cardiology Deparment
Hospital Universitario Infanta Cristina