The ROLEX Registry (Revascularization Of LEft Main With Resolute onyX) A Multicenter Prospective Registry of the Onyx Resolute Stent for the Treatment of Unprotected Left Main Coronary Artery Disease.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 450
- 试验地点
- 33
- 主要终点
- target lesion failure
研究概览
简要总结
The primary objective of this study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent Resolute Onyx in the treatment of unprotected left main coronary artery disease (ULMCAD), both isolated or in association with two- or three-vessel coronary artery disease.
详细描述
The ROLEX study is a prospective, non-randomized, European, multi-center registry.
Four hundred and fifty patients with unprotected left main coronary artery disease (ULMCAD) will be enrolled at up to 40 European sites. The main objective of the study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent Resolute Onyx in the treatment of ULMCAD, both isolated or in association with two- or three-vessel coronary artery disease
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject > 18 years old
- •ULMCAD with angiographic diameter stenosis >50% (if 50-70% evidence of FFR <0.80 or IVUS minimal lumen area <6.0 mm2 is recommended.
- •Silent ischemia, stable angina, unstable angina or non-ST elevation myocardial infarction
- •Ability to provide written informed consent and comply with follow-up for at least 2 years.
排除标准
- •Clinical exclusion criteria:
- •Prior PCI on the left main trunk or prior CABG.
- •Concomitant indication to cardiac surgery (severe heart valve disease etc.)
- •Cardiogenic Shock (Killip>2)
- •Severe renal insufficiency (GFR <30 ml/min)
- •Known impaired left ventricular function (left ventricular ejection fraction <30%)
- •Inability to tolerate or comply with dual antiplatelet therapy for at least 1 year
- •Pregnancy or intention to become pregnant
- •Life expectancy less than 1 year
- •Other investigational drug or device studies that have not reached their primary endpoint
- •Angiographic exclusion criteria:
- •Left main diameter stenosis <50%
- •SYNTAX score >33
结局指标
主要结局
target lesion failure
时间窗: 12 months
composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization
次要结局
未报告次要终点