Retrospective Algorithm Validation of IVUS-FFR in Patients

This is a retrospective, single-center study to develop and validate an updated algorithm for computing fractional flow reserve from intravascular ultrasound images (IvusFFR v2.0). The study will use existing intravascular ultrasound (IVUS) images and corresponding invasive fractional flow reserve (FFR) measurements obtained from approximately 100 patients who underwent clinically indicated coronary angiography, IVUS, and FFR assessment at Fuwai Hospital. All data will be anonymized prior to analysis. The primary objective is to assess the diagnostic accuracy of IvusFFR v2.0 in identifying hemodynamically significant coronary stenosis, using wire-based FFR ≤0.80 as the reference standard. This study involves no prospective intervention or additional patient contact.

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Key information

Conditions

Coronary Artery Disease Algorithm Validation for Fractional Flow Reserve Derived From Intravascular Ultrasound Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai hospital

Beijing, Select, 100037, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥18 years.
Underwent clinically indicated coronary angiography, intravascular ultrasound (IVUS) imaging, and invasive fractional flow reserve (FFR) measurement at Fuwai Hospital.
IVUS pullback imaging of sufficient quality for analysis, covering the entire lesion segment of interest.
Valid FFR measurement recorded.
Presence of at least one native coronary artery stenosis with visual diameter stenosis between 30% and 90%.

Exclusion criteria

Chronic total occlusion (CTO) of the target vessel.
Prior coronary artery bypass grafting (CABG) involving the target vessel.
IVUS pullback did not cover the entire lesion.
Severe myocardial bridge or vessel spasm in the interrogated vessel.
Substantial thrombosis or dissection identified by IVUS.
Image quality deemed inadequate for analysis by two independent analysts.

Treatment and study plan

No Intervention (Retrospective Data Analysis)

Other

This is a retrospective observational study. No prospective intervention is administered. Participants' existing IVUS images and FFR measurements are analyzed.

Primary outcomes

Diagnostic Accuracy of IvusFFR v2.0 for Identifying Hemodynamically Significant Coronary Stenosis

Time frame: Through study completion, an average of 6 months

Diagnostic accuracy of IvusFFR v2.0 in identifying hemodynamically significant coronary stenosis, using wire-based fractional flow reserve (FFR) ≤0.80 as the reference standard. Accuracy is defined as (True Positive + True Negative) / (Total Number of Vessels).

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Retrospective Algorithm Development and Validation of Intravascular Ultrasound-Derived Fractional Flow Reserve (IvusFFR): A Single-Center Study in Patients

Acronym: V-IVUS_FFR

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Apr 27, 2026
Registry last updated: Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed