OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound. The OPTIMAL Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 806
- 试验地点
- 28
- 主要终点
- Patient-oriented Composite Endpoint (POCE)
研究概览
简要总结
The OPTIMAL study is a randomized, controlled, multicentre, international study. A total of 800 patients will be randomized in a 1:1 fashion to Intravascular Ultrasound (IVUS)-guided PCI versus qualitative angio(QCA)-guided Percutaneous Coronary Intervention (PCI). Patients will be consented prior to the PCI procedure and then followed up to 2 years after the index procedure for the last enrolled patient. Patients will be followed-up at 1 month (telephone contact), 12 months (outpatient clinic visit or telephone call) and yearly after (outpatient clinic visit or telephone call).
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
- •The patient must be ≥ 18 years of age;
- •De novo lesion in an unprotected left main coronary artery (ULMCA; ostial, shaft or distal) OR ostial left anterior descending artery (LAD) or ostial circumflex (LCX), both compatible with one Medina class of LM disease; or ostial intermediate branch disease;
- •PCI is considered appropriate and feasible by the treating interventionalist;
- •Silent ischemia, stable angina, unstable angina, or non-ST segment elevation MI;
- •Able to understand and provide informed consent and comply with all study procedures, including follow-up for at least 2 years.
- •Note: A patient with a prior CABG with no patent bypass on the left main coronary artery (LMCA) can be included.
排除标准
- •Patient is a woman who is pregnant or nursing;
- •Female patient of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause);
- •IVUS is strictly required for pre-PCI lesion severity assessment
- •ST-elevation myocardial infarction, cardiogenic shock;
- •Previous history of CABG with patent graft to the LAD and/or patent graft to the LCX;
- •Prior PCI of the LM, ostial LAD or ostial LCX at any time prior to enrollment;
- •Prior PCI of any other (i.e. non-LM, non-ostial-LAD and non-ostial-LCX) coronary artery lesions within 30 days prior to enrollment;
- •Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 6 months in stable patients and 1 year in ACS patients;
- •Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants.
- •Patients requiring additional surgery (cardiac or non-cardiac) within 3 months post-enrollment;
- •Non-cardiac co-morbidities with a life expectancy less than 2 years;
- •Currently participating in another trial that is not yet at its primary endpoint. The patient is not allowed to participate in another investigational device or drug study for at least 12 months after enrollment.
研究组 & 干预措施
IVUS guided PCI
Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.
干预措施: IVUS guided Percutaneous Coronary Intervention (Device)
Angiography-guided PCI
Qualitative or quantitative angiography will be used to determine lesion characteristics
干预措施: Qualitative or quantitative angiography will guide percutaneous coronary intervention (Device)
结局指标
主要结局
Patient-oriented Composite Endpoint (POCE)
时间窗: 2-5 years follow up
Patient-oriented Composite Endpoint (PoCE): composite of all-cause death, any stroke, any myocardial infarction (MI)\*, any clinically indicated revascularization at longest follow-up.
次要结局
- Device-oriented Composite Endpoint (DoCE)(2-5 years follow up)
- Vessel-oriented Composite Endpoint (VoCE)(2-5 years follow up)
- Patient-oriented Composite Endpoint (POCE)(2 year follow up)
- All individual components of PoCE at all time points.(2-5 years follow-up)
- All individual components of DoCE at all time points.(2-5 years follow-up)
- Definite and probable stent thrombosis(2-5 years follow-up)
- Hospitalization for heart failure(2-5 years follow-up)