跳至主要内容
临床试验/NCT03394079
NCT03394079进行中(未招募)不适用

A Prospective, Open Label, Multi-center, Dual Arm, Randomized, Pragmatic Trial : Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention

Seung-Jung Park9 个研究点 分布在 1 个国家目标入组 2,008 人开始时间: 2018年4月12日最近更新:
适应症

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

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

发起方
Seung-Jung Park
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

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

研究点 (9)

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