NCT07551518Completed
Retrospective Algorithm Validation of IVUS-FFR in Patients
Retrospective Algorithm Development and Validation of Intravascular Ultrasound-Derived Fractional Flow Reserve (IvusFFR): A Single-Center Study in Patients
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 19 Apr 2026
- Start date
- 1 Dec 2024
- Primary completion date
- 30 May 2025
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- Coronary artery disease
- NCT number
- NCT07551518
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 1 Dec 2024 to the primary completion date, 30 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior coronary artery bypass grafting (CABG) involving the target vessel.
Other illness
- Severe myocardial bridge or vessel spasm in the interrogated vessel.
- Substantial thrombosis or dissection identified by IVUS.
Other
- Chronic total occlusion (CTO) of the target vessel.
- IVUS pullback did not cover the entire lesion.
- Image quality deemed inadequate for analysis by two independent analysts.
Who the study is looking for
- 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%.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.