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NCT07551518

Retrospective Algorithm Validation of IVUS-FFR in Patients

Sponsor: China National Center for Cardiovascular Diseases

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-12-01

Completion Date

2025-05-30

Last Updated

2026-04-27

Healthy Volunteers

No

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.

Locations (1)

Fuwai hospital

Beijing, Select, China