Retrospective Algorithm Development and Validation of Intravascular Ultrasound-Derived Fractional Flow Reserve (IvusFFR): A Single-Center Study in Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of IvusFFR v2.0 for Identifying Hemodynamically Significant Coronary Stenosis
研究概览
简要总结
This is a retrospective, single-center study to develop and validate an updated algorithm for computing fractional flow reserve from intravascular ultrasound images (IvusFFR v2.0). The study will use existing intravascular ultrasound (IVUS) images and corresponding invasive fractional flow reserve (FFR) measurements obtained from approximately 100 patients who underwent clinically indicated coronary angiography, IVUS, and FFR assessment at Fuwai Hospital. All data will be anonymized prior to analysis. The primary objective is to assess the diagnostic accuracy of IvusFFR v2.0 in identifying hemodynamically significant coronary stenosis, using wire-based FFR ≤0.80 as the reference standard. This study involves no prospective intervention or additional patient contact.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age ≥18 years.
- •Underwent clinically indicated coronary angiography, intravascular ultrasound (IVUS) imaging, and invasive fractional flow reserve (FFR) measurement at Fuwai Hospital.
- •IVUS pullback imaging of sufficient quality for analysis, covering the entire lesion segment of interest.
- •Valid FFR measurement recorded.
- •Presence of at least one native coronary artery stenosis with visual diameter stenosis between 30% and 90%.
排除标准
- •Chronic total occlusion (CTO) of the target vessel.
- •Prior coronary artery bypass grafting (CABG) involving the target vessel.
- •IVUS pullback did not cover the entire lesion.
- •Severe myocardial bridge or vessel spasm in the interrogated vessel.
- •Substantial thrombosis or dissection identified by IVUS.
- •Image quality deemed inadequate for analysis by two independent analysts.
研究组 & 干预措施
Retrospective IVUS-FFR Cohort
This single retrospective cohort consists of approximately 100 patients who underwent clinically indicated coronary angiography, intravascular ultrasound (IVUS) imaging, and invasive fractional flow reserve (FFR) measurement at Fuwai Hospital. All data were collected as part of routine clinical care and have been fully anonymized prior to analysis. The cohort includes both pre- and post-percutaneous coronary intervention (PCI) pullbacks where available. No prospective intervention or patient contact is involved. The dataset is used for algorithm development and validation of IvusFFR v2.0, a software for computing FFR from IVUS images.
干预措施: No Intervention (Retrospective Data Analysis) (Other)
结局指标
主要结局
Diagnostic Accuracy of IvusFFR v2.0 for Identifying Hemodynamically Significant Coronary Stenosis
时间窗: Through study completion, an average of 6 months
Diagnostic accuracy of IvusFFR v2.0 in identifying hemodynamically significant coronary stenosis, using wire-based fractional flow reserve (FFR) ≤0.80 as the reference standard. Accuracy is defined as (True Positive + True Negative) / (Total Number of Vessels).
次要结局
未报告次要终点
研究者
Kefei Dou, MD
Kefei Dou, MD, Professor, China National Center for Cardiovascular Diseases
China National Center for Cardiovascular Diseases