Diagnostic Accuracy of CFD-Based Fractional Flow Reserve Derived From Coronary Angiography

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT04814550
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

This is a prospective, multicenter, self-control clinical trial designed to assess the efficacy of AccuFFRangio, a novel method for evaluating the functional significance of coronary stenosis from coronary angiography, with FFR as the reference standard.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-04
• Study First Submitted: 2020-12-06
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Primary Completion: 2021-06-28
• Study Completion: 2022-02-24
• Status Verified: 2022-12
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

Inclusion Criteria

• Age ≥18 years;
• Stable or unstable angina, or myocardial infarction after the acute phase, indication for FFR in at least one vessel;
• Able to provide informed consent.

Exclusion Criteria

• Subjects judged unsuitable for diagnostic intervention or FFR;
• Myocardial infarction within 6 days;
• LVEF ≤50%;
• eGFR <60ml/min（1.73m²）
• Severe coagulation dysfunction or bleeding disorders;
• Allergic to iodine contrast agent or adenosine, or ineligible for adenosine;
• Participated in other clinical trials within 1 months;
• Other situations that were not suitable for inclusion, as judged by investigators.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard	7 days	Hemodynamically significant coronary artery stenosis: FFR≤0.8

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard	7 days	Hemodynamically significant coronary artery stenosis: FFR≤0.8
AUC of AccuFFRangio for discrimination of hemodynamically significant coronary artery stenosis	7 days	Hemodynamically significant coronary artery stenosis: FFR≤0.8

Trial Locations

Locations (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hanzhou, Zhejiang, China