IVUS-FFR Accuracy for Coronary Stenosis

NCT07446023 | Recruiting DMC

• 1 other identifier: 2024-2463
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Percutaneous Coronary Intervention; Intravenous Ultrasound; Coronary Physiology

Keywords

Percutaneous Coronary Intervention; Intravenous Ultrasound; Coronary Physiology; Fractional Flow Reserve; IVUS-FFR; Diagnostic Accuracy

Outcome Measures

Primary Outcomes (2)

• 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.

  Single time point assessment: immediately after IVUS-FFR computation during the index cardiac catheterization procedure.

• 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%.

  Single assessment at time of index cardiac catheterization procedure.

Study Arms (1)

IVUS-FFR Online Assessment

EXPERIMENTAL

Intervention Protocol Participants receive a real-time functional coronary evaluation using the integrated IVUS-FFR system during diagnostic angiography. The procedure consists of three sequential phases: IVUS Image Acquisition A clinically approved IVUS catheter (40MHz frequency) is advanced to the target coronary segment Standardized automated pullback (0.5 mm/sec) captures cross-sectional vessel images Minimum imaging length: 30mm proximal-to-distal to stenosis Real-Time Computational Analysis DICOM data transfer to IVUS-FFR processing platform AI-driven segmentation of: Lumen boundaries External elastic lamina (EEL) Plaque morphology Hemodynamic simulation using: Adaptive blood flow models based on Murray's law Branching-specific flow distribution algorithms Processing time: ≤90 seconds Diagnostic Output Delivery Primary metric: Computed IVUS-FFR value (scale 0-1) Clinical threshold: IVUS-FFR ≤0.80 = hemodynamically significant stenosis Quality control: Auto

Diagnostic Test: Ultrasound-Derived Fractional Flow Reserve Computational System

Interventions

Ultrasound-Derived Fractional Flow Reserve Computational System DIAGNOSTIC_TEST

1. 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

IVUS-FFR Online Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (3)

• Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1.

  PMID: 26347918 RESULT

• Smits PC, Abdel-Wahab M, Neumann FJ, Boxma-de Klerk BM, Lunde K, Schotborgh CE, Piroth Z, Horak D, Wlodarczak A, Ong PJ, Hambrecht R, Angeras O, Richardt G, Omerovic E; Compare-Acute Investigators. Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction. N Engl J Med. 2017 Mar 30;376(13):1234-1244. doi: 10.1056/NEJMoa1701067. Epub 2017 Mar 18.

  PMID: 28317428 RESULT

• Zimmermann FM, Omerovic E, Fournier S, Kelbaek H, Johnson NP, Rothenbuhler M, Xaplanteris P, Abdel-Wahab M, Barbato E, Hofsten DE, Tonino PAL, Boxma-de Klerk BM, Fearon WF, Kober L, Smits PC, De Bruyne B, Pijls NHJ, Juni P, Engstrom T. Fractional flow reserve-guided percutaneous coronary intervention vs. medical therapy for patients with stable coronary lesions: meta-analysis of individual patient data. Eur Heart J. 2019 Jan 7;40(2):180-186. doi: 10.1093/eurheartj/ehy812.

  PMID: 30596995 RESULT

Study Officials

• Kefei Dou, MD

  Chinese Academy of Medical Sciences and Peking Union Medical College

  STUDY CHAIR

Central Study Contacts

Kefei Dou, Principal Investigator

CONTACT

15980609858; drdoukefei@126.com

Zhihao Zheng, MD

CONTACT

15980609858; fwzh97@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kefei Dou, MD, Professor, China National Center for Cardiovascular Diseases

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: March 3, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

CN (1)