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Retrospective Algorithm Validation of IVUS-FFR in Patients

NCT07551518 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-04-27

No results posted yet for this study

Summary

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.

Conditions

  • Coronary Artery Disease
  • Coronary Stenosis
  • Algorithm Validation for Fractional Flow Reserve Derived From Intravascular Ultrasound

Interventions

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.

Sponsors & Collaborators

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-05-30
Completion
2025-05-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07551518 on ClinicalTrials.gov