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

Zhejiang University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Diagnostic Test: FFR

Study type: Observational

Funder types: Other

Identifiers

NCT04814550

2020-153

Details and patient eligibility

About

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.

Enrollment: 318 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.