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

Coronary Artery Disease Clinical Trial

— ACCURATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814550
• Other study ID #: 2020-153
• Status: Completed
• Start date: November 4, 2020
• Est. completion date: February 24, 2022

Study information

• Verified date: December 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: February 24, 2022
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• FFR
FFR measured by pressure wire, AccuFFRangio computed by coronary angiographic images

Locations

Country	Name	City	State
China	The Second Affiliated Hospital, Zhejiang University School of Medicine	Hanzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard	Hemodynamically significant coronary artery stenosis: FFR=0.8	7 days
Secondary	Sensitivity and specificity of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard	Hemodynamically significant coronary artery stenosis: FFR=0.8	7 days
Secondary	AUC of AccuFFRangio for discrimination of hemodynamically significant coronary artery stenosis	Hemodynamically significant coronary artery stenosis: FFR=0.8	7 days