Influence of Novel Intravascular Ultrasound-Based Artificial Intelligence Technologies on Event Reduction Following Percutaneous Coronary Intervention (INNOVATE-PCI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 32
- 主要终点
- nonculprit-related TVF
研究概览
简要总结
This study is a prospective, multicenter study in the real practice to validate the diagnostic performances and clinical impact of coronary angiography & intravascular ultrasound (IVUS)-based models developed by machine learning (ML).
详细描述
The aim of the study is to evaluate the performances and prognostic impact of coronary angiography & IVUS-based algorithms for decision making and stent optimization in a multicenter, prospective cohort. Between January 2020 and June 2027, a total of 3,000 patients who performed coronary angiography (± FFR) and have at least one coronary stenosis requiring PCI (as culprit) will be enrolled from 16 centers in South Korea. In addition, the deferred lesions with visual estimated diameter stenosis of >30% will be evaluated as non-culprits. Brief study design is as depicted in the following figure.
Supervised ML algorithms include: 1) angiography- and IVUS-based algorithms for predicting FFR, 2) IVUS-based algorithm for plaque characterization, 3) IVUS-based algorithm for predicting stent expansion, and 4) post-stenting IVUS-based algorithm for predicting stent failure. In the prospective cohort, the performance of each model will be assessed. This registry trial composed of the treated (culprit) and the deferred (nonculprit) coronary lesions has two primary objectives as follow; 1) Primary objectives in treated (culprit) lesions is to see the impact of the integrated ML model on the development of culprit-related 2-year target vessel failure (TVF). 2) Primary objectives in deferred (nonculprit) lesions is to see the impact of the integrated ML model on the development of nonculprit-related 2-year TVF.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age 19 years or older
- •Symptomatic angina patients with objective myocardial ischemia
- •Patients with at least one major epicardial coronary artery that requires stent implantation
- •Subject who signs with informed consent form
排除标准
- •ST-segment elevation MI at admission
- •Patients who underwent coronary artery bypass surgery or heart transplantation
- •Left ventricular ejection fraction <30%
- •Cardiogenic shock
- •Patients whose life expectancy <2 years
- •Woman who are breastfeeding, pregnant or planning to become pregnant during study
- •Patients in whom anti-platelets or heparin is contraindicated
- •Lesion exclusion Criteria:
- •Left main culprit lesion (angiographic diameter stenosis >50%)
- •Thrombus-containing lesion
- •In-stent restenosis
- •Side branch lesion
- •Chronic total occlusion
- •Small vessel with reference diameter <2.5mm
- •Coronary spasm despite administration of nitrate
- •Inability for imaging catheter to pass through tight stenosis, calcification, angulations
- •Poor image quality
- •Angiographically visible collateral vessels
结局指标
主要结局
nonculprit-related TVF
时间窗: 2 years after stent implantation
composite of cardiac death, MI, and clinically-driven TVR at 2 years
culprit-related TVF
时间窗: 2 years after stent implantation
composite of cardiac death, myocardial infarction (MI), stent thrombosis, and clinically-driven target vessel revascularization (TVR) at 2 years after SynergyTM implantation
次要结局
- each component of primary measures(2 years after stent implantation)
- all cause death(2 years after stent implantation)
- repeat revascularization(2 years after stent implantation)
- stroke(2 years after stent implantation)
- bleeding(2 years after stent implantation)
研究者
Seung-Whan Lee, M.D., Ph.D.
Principal Investigator
Asan Medical Center