Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country318 target enrollmentNovember 4, 2020

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment: 318
Locations: 1
Primary Endpoint: Diagnostic accuracy of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 4, 2020

End Date

February 24, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Diagnostic accuracy of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard

Time Frame: 7 days

Hemodynamically significant coronary artery stenosis: FFR≤0.8

Secondary Outcomes

Sensitivity and specificity of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard(7 days)
AUC of AccuFFRangio for discrimination of hemodynamically significant coronary artery stenosis(7 days)