A Prospective, Open Label, Multi-center, Dual Arm, Randomized, Pragmatic Trial : Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,008
- 试验地点
- 9
- 主要终点
- Rate of target vessel failure
研究概览
简要总结
The primary aim of this study is to compare the clinical efficacy and safety of OCT-guided(optical coherence tomography (OCT)-guided) and IVUS-guided(Intravascular ultrasound (IVUS)-guided) strategies in patients undergoing Percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) or drug-coated balloons (only for in-stent restenosis) for significant obstructive Coronary artery disease (CAD).
The investigators hypothesize that OCT-guided PCI is non-inferior to IVUS-guided PCI with respect to primary end point of target-vessel failure (cardiac death, target-vessel myocardial infarction [MI], or ischemia-driven target-vessel revascularization [TVR]) at 1 year after randomization.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women at least 19 years of age
- •Subjects with obstructive CAD undergoing PCI with contemporary DES or drug-coated balloons (only for in-stent restenosis) under intracoronary imaging guidance.
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •ST-elevation myocardial infarction
- •Severe renal dysfunction (eGFR <30 ml/min/1.73 m2 or serum creatinine level >1.5 mg/dl), unless patient is on renal replacement therapy.
- •Cardiogenic shock or decompensated heart failure with severe LV dysfunction (LVEF) < 30%
- •Life expectancy < 1 year for any non-cardiac or cardiac causes
- •Any lesion characteristics resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre- and post-PCI (eg, moderate or severe vessel calcification or tortuosity)
- •Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study
- •Unwillingness or inability to comply with the procedures described in this protocol
结局指标
主要结局
Rate of target vessel failure
时间窗: 1 year
A composite of cardiac death, target-vessel MI or ischemia-driven TVR) at 1 year after randomization. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.
次要结局
- Rate of stent thrombosis(1, and 5 years)
- Rate of target-lesion failure(1, and 5 years)
- Rate of angiographic or imaging-based device success(1 day)
- Rate of cardiac Death(1, and 5 years)
- Rate of death(1, and 5 years)
- Rate of repeat revascularization(1, and 5 years)
- Rate of any hospitalization(1, and 5 years)
- Rate of myocardial infarction(1, and 5 years)
- Rate of target vessel myocardial infarction(1, and 5 years)
- Rate of ischemia-driven target vessel revascularization(1, and 5 years)
- Rate of contrast-induced acute kidney injury(3 days)
- Rate of stroke(1, and 5 years)
- Rate of bleeding events(1, and 5 years)
- Rate of procedural complications requiring active intervention that were related to PCI or intracoronary imaging devices(1 day)
研究者
Seung-Jung Park
Professor, Division of Cardiology, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea
Asan Medical Center