IVUS-FFR Accuracy for Coronary Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases
About this trial
IVUS-FFR Online Accuracy for Coronary Stenosis What is this study testing? This study is testing a new technology called IVUS-FFR , which uses ultrasound imaging inside heart arteries (IVUS) to quickly measure whether a narrowed artery ( coronary stenosis ) is reducing blood flow. Unlike the current standard test (FFR), this new method doesn't require extra wires or medication to work.
Why is this important?
Many patients with heart artery narrowing need tests to decide if a stent is necessary.
Current FFR tests involve inserting a pressure wire and giving medication (like adenosine) that can cause discomfort.
IVUS-FFR could provide equally accurate results faster, cheaper, and more comfortably .
What happens in the study?
If you join:
Standard heart artery imaging (angiogram) will be performed. An ultrasound probe (IVUS) will be moved through the artery to create detailed images.
The new IVUS-FFR software will analyze these images immediately to estimate blood flow.
For comparison, a standard FFR test (with pressure wire and medication) will also be done.
All steps use existing approved devices and take \<10 extra minutes. Who can participate?
Adults (≥18 years) with:
Suspected or known heart artery disease At least one artery narrowing (30%-90% blocked) Excluded: Recent heart attack (\<72 hrs), severe kidney/heart failure, or pregnancy.
What are the risks and benefits?
Risks: Same as routine heart catheterization (bleeding, infection, artery injury). The IVUS and FFR steps add minimal extra risk.
Benefits: No direct benefit, but results may improve future care by reducing need for invasive tests.
Study goal:
To validate if IVUS-FFR is as accurate as the current FFR standard in 292 patients across multiple hospitals in China.
Who is running the study? Led by heart specialists at Fuwai Hospital (Beijing) - China's top cardiovascular center - with ethics committee oversight.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age Diagnosed with stable/unstable angina or post-acute phase myocardial infarction (>72 hours after onset) Able to comprehend study design and provide written informed consent Angiographic & IVUS-Specific Requirements
1 epicardial coronary artery with 30%-90% visual diameter stenosis Reference vessel diameter ≥2.0 mm at target stenosis site
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Ultrasound-Derived Fractional Flow Reserve Computational System
Diagnostic test1. Core Technological Innovation This diagnostic system revolutionizes coronary stenosis assessment by integrating intravascular ultrasound (IVUS) imaging with real-time computational physiology . Its proprietary technology features: AI-driven vessel segmentation : Deep neural networks automatically delineate lumen boundaries and external elastic lamina from IVUS images, enabling millimeter-level precision in 3D coronary reconstruction. Dynamic hemodynamic modeling : Adaptive algorithms apply Murray's law to calculate branch-specific blood flow distribution, accounting for plaque composition (calcified/fibrous/lipidic) and vessel tapering. 2. Procedural Implementation The intervention seamlessly integrates into standard coronary angiography workflows: Image acquisition : A 40MHz IVUS catheter performs automated pullback (0.5 mm/sec) across the target stenosis and adjacent segments. Real-time processing : DICOM data transfers to an embedded GPU server, initiat
Treatment groups
292 Participants
are divided into 1 treatment groupGroup A: IVUS-FFR Online AssessmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic Accuracy of IVUS-FFR in Identifying Hemodynamically Significant Coronary Stenosis
Diagnostic accuracy of IVUS-FFR (online, HRU100) vs. invasive FFR (pressure wire, adenosine) for functionally significant stenosis (≤0.80). Primary metric: proportion of correct classifications (true positives + true negatives) among all lesions. Secondary metrics: sensitivity, specificity, PPV, NPV, AUC. Measurement: paired real-time assessment; IVUS-FFR computed during catheterization, then FFR measured. Blinding: IVUS-FFR operator blinded to FFR result until after recording. Quality assurance: core lab verification; analyses with segmentation confidence \<95% rejected.
Time frame
Single time point assessment: immediately after IVUS-FFR computation during the index cardiac catheterization procedure.2
Diagnostic Accuracy of IVUS-FFR in Identifying Hemodynamically Significant Coronary Stenosis
This outcome measures the diagnostic performance of IVUS-FFR (computed online during catheterization using the HRU100 system) against the gold standard invasive FFR (measured with a pressure wire under adenosine-induced hyperemia). Functionally significant stenosis is defined as ≤0.80 for both methods. The primary metric is the proportion of correct classifications (true positives + true negatives) among all evaluated lesions. Secondary metrics derived from the same data include sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve. Measurement Method: Paired real-time assessment: IVUS-FFR computed first, immediately followed by invasive FFR measurement. Blinding: IVUS-FFR operator masked to FFR result until after recording. Quality Assurance: Core laboratory verification of all measurements; automatic rejection of analyses with segmentation confidence \<95%.
Time frame
Single assessment at time of index cardiac catheterization procedure.Sponsors and contacts
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Source ClinicalTrials.gov