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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04814550

Acronym

ACCURATE

Enrollment

318

Registered

2021-03-24

Start date

2020-11-04

Completion date

2022-02-24

Last updated

2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DIAGNOSTIC_TESTFFR

FFR measured by pressure wire, AccuFFRangio computed by coronary angiographic images

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026