Retrospective Algorithm Validation of IVUS-FFR in Patients (V-IVUS_FFR)

April 19, 2026 updated by: Kefei Dou, MD, China National Center for Cardiovascular Diseases

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Select
      • Beijing, Select, China, 100037
        • Fuwai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This retrospective study includes approximately 100 adult patients with suspected or known coronary artery disease who underwent clinically indicated invasive coronary angiography, intravascular ultrasound (IVUS) imaging, and fractional flow reserve (FFR) measurement at Fuwai Hospital. The cohort consists of patients with intermediate coronary lesions (30-90% diameter stenosis by visual estimation) for whom both anatomical assessment by IVUS and physiological assessment by FFR were deemed clinically necessary. Data were collected from existing medical records and imaging archives, and all personal identifiers have been removed prior to analysis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective IVUS-FFR Cohort
This single retrospective cohort consists of approximately 100 patients who underwent clinically indicated coronary angiography, intravascular ultrasound (IVUS) imaging, and invasive fractional flow reserve (FFR) measurement at Fuwai Hospital. All data were collected as part of routine clinical care and have been fully anonymized prior to analysis. The cohort includes both pre- and post-percutaneous coronary intervention (PCI) pullbacks where available. No prospective intervention or patient contact is involved. The dataset is used for algorithm development and validation of IvusFFR v2.0, a software for computing FFR from IVUS images.
Other: No Intervention (Retrospective Data Analysis)
This is a retrospective observational study. No prospective intervention is administered. Participants' existing IVUS images and FFR measurements are analyzed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

May 30, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

April 19, 2026

First Submitted That Met QC Criteria

April 19, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 19, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-2321

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe