Clinical Trial

Retrospective Algorithm Validation of IVUS-FFR in Patients

Study acronym: V-IVUS_FFR
Completed
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.
Trial Details
NCT Number NCT07551518
Lead Sponsor China National Center for Cardiovascular Diseases
Conditions Coronary Artery Disease, Coronary Stenosis, Algorithm Validation for Fractional Flow Reserve Derived From Intravascular Ultrasound
Enrollment 100 participants
Start Date 2024-12-01
Primary Completion 2025-05-30 (estimated)
Study Completion 2025-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-27