Percutaneous Coronary InterventionIVUS-FFRNCT07446023
IVUS-FFR Accuracy for Coronary Stenosis
A study testing Ultrasound-Derived Fractional Flow Reserve Computational System in people with Percutaneous Coronary Intervention and Intravenous Ultrasound, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Intravenous Ultrasound, Coronary Physiology
- What is being tested?
- Ultrasound-Derived Fractional Flow Reserve Computational System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Exclusion Criteria General Exclusions Contraindications to invasive procedures/FFR per operator judgment Acute myocardial infarction within 72 hours Cardiogenic shock or severe heart failure (NYHA class ≥III or LVEF <30%) Severe renal dysfunction (Creatinine >150 μmol/L or eGFR <45 mL/min/1.73m²) Allergy to iodinated contrast media or adenosine Pregnancy/lactation Life expectancy <1 year Concurrent participation in other interventional trials Angiographic \& IVUS-Specific Exclusions Myocardial bridging at target lesion Severely calcified or tortuous vessels precluding safe IVUS Isolated >90% stenosis with TIMI flow grade <3 in major epicardial artery Other conditions deemed unsuitable for IVUS/FFR by investigators
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai hospital
Beijing, Beijing Municipality, 100037
Zhihao Zheng, MD, 15980609858, fwzh97@126.com
Zhihao Zheng, MD, fwzh97@126.com
About this study
Official title: Diagnostic Accuracy of Intravascular Ultrasound-Derived Fractional Flow Reserve for Online Assessment of Functionally Significant Coronary Stenosis: A Multicenter Prospective Study
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?
Read more
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.
Read the detailed description
- Introduction and Study Rationale This study focuses on developing and validating an innovative technology called IVUS-derived Fractional Flow Reserve (IVUS-FFR), which aims to address limitations in current methods for assessing coronary artery stenosis. Coronary artery disease often requires precise evaluation of blood flow restrictions to determine if interventions like stents are necessary. The gold standard, Fractional Flow Reserve (FFR), involves invasive pressure wires and vasodilator drugs (e.g., adenosine), leading to increased costs, procedural time, and potential complications such as allergic reactions or hemodynamic instability. By contrast, IVUS-FFR integrates intravascular ultrasound imaging with computational fluid dynamics to estimate functional significance without additional devices or medications. This approach could streamline clinical workflows, reduce patient discomfort, and lower healthcare expenses, making it a promising advancement in cardiovascular diagnostics.
- Primary Research Objectives The core goal is to evaluate the diagnostic accuracy of the IVUS-FFR system in identifying hemodynamically significant coronary stenosis, defined as a reduction in blood flow warranting intervention. Using a prospective, multicenter design, the study directly compares IVUS-FFR against FFR as the reference standard. Secondary objectives include assessing feasibility in real-time catheterization lab settings, establishing standardized operational protocols, and refining the technology for broader clinical adoption. Additionally, the study will contrast IVUS-FFR with quantitative coronary angiography (QCA), an anatomical assessment tool, to demonstrate superior diagnostic performance in detecting functionally relevant lesions.
- Study Design and Methodology Overview This research employs a prospective, multicenter, self-controlled clinical trial framework. It targets enrollment of 292 adult participants with suspected or confirmed coronary artery disease, specifically those exhibiting at least one visually estimated coronary stenosis between 30% and 90% diameter reduction. Participants undergo sequential assessments: first, standard coronary angiography and IVUS imaging to generate detailed vascular reconstructions; second, immediate online IVUS-FFR analysis using proprietary algorithms; and third, conventional FFR measurement for validation. Blinding protocols ensure objectivity-IVUS-FFR operators are unaware of FFR results during analysis, and an independent core lab processes QCA data. Statistical methods include receiver operating characteristic (ROC) curves to calculate area under the curve (AUC), sensitivity and specificity analyses, and Delong tests for comparing IVUS-FFR and QCA performance. The sample size provides 90% statistical power to detect a target diagnostic accuracy of 83% for IVUS-FFR.
- Technological Innovations and Workflow Integration The IVUS-FFR system represents a significant leap in computational physiology. It combines high-frequency intravascular ultrasound (40MHz probes) with artificial intelligence-driven segmentation. This involves deep neural networks to automatically delineate vessel structures, such as the lumen and external elastic lamina, enabling precise 3D vascular modeling. Blood flow simulations leverage Murray's law for adaptive hemodynamic calculations, ensuring accurate pressure drop estimations across stenoses. Key innovations include real-time processing capabilities-results are generated within 90 seconds of IVUS data acquisition-and compatibility with existing catheterization lab equipment. This integration minimizes workflow disruptions, adding less than 10 minutes to standard procedures while eliminating the need for pressure wires or vasodilators.
- Participant Eligibility and Ethical Safeguards Eligible participants are adults aged 18 years or older with coronary artery disease symptoms, such as stable or unstable angina, who are scheduled for diagnostic angiography. Exclusion criteria prioritize safety, excluding individuals with recent myocardial infarction (within 72 hours), severe heart failure, significant kidney impairment, pregnancy, or contraindications to iodinated contrast agents. All participants provide informed consent, and the study adheres to stringent ethical oversight through Fuwai Hospital's institutional review board. Rigorous risk mitigation strategies include protocolized management of potential complications like vessel injury during IVUS catheterization and on-site emergency resources for adenosine-related adverse events.
- Expected Outcomes and Broader Implications Upon completion, the study aims to validate IVUS-FFR as a non-inferior alternative to FFR, with anticipated diagnostic accuracy exceeding 83%. This could establish new clinical standards, reducing reliance on invasive FFR and cutting procedural costs by approximately $850 per case. Broader impacts include intellectual property development, such as 2-3 national patents for the core algorithms and 1-2 software copyrights. Dissemination will occur through high-impact publications in Q1-ranked journals and presentations at international conferences, potentially influencing future guidelines on coronary revascularization. If successful, IVUS-FFR could extend to peripheral vascular applications, enhancing patient outcomes globally by enabling faster, safer, and more accessible functional assessments.
- Being tested
- Ultrasound-Derived Fractional Flow Reserve Computational System
- Keywords
- Percutaneous Coronary Intervention, Intravenous Ultrasound, Coronary Physiology, Fractional Flow Reserve, IVUS-FFR, Diagnostic Accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Derived Fractional Flow Reserve Computational SystemDiagnostic test
- 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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Ultrasound-Derived Fractional Flow Reserve Computational System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: Single assessment at time of index cardiac catheterization procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kefei Dou, MD, China National Center for Cardiovascular Diseases
- Investigators
- Kefei Dou, MD, Study chair, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446023
- Sponsor's protocol ID
- 2024-2463
- Acronym
- IVUS-FFR
- Status last verified
- Feb 2026
- First submitted
- 13 Jul 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26347918Smits 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.
PubMed 28317428Zimmermann 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.
PubMed 30596995
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Intravascular Ultrasound-Derived Fractional Flow Reserve for Online Assessment of Functionally Significant Coronary Stenosis: A Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT07446023
- Acronym / sponsor ID
- IVUS-FFR / 2024-2463
- Keywords
- Percutaneous Coronary Intervention, Intravenous Ultrasound, Coronary Physiology, Fractional Flow Reserve, IVUS-FFR, Diagnostic Accuracy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Introduction and Study Rationale This study focuses on developing and validating an innovative technology called IVUS-derived Fractional Flow Reserve (IVUS-FFR), which aims to address limitations in current methods for assessing coronary artery stenosis. Coronary artery disease often requires precise evaluation of blood flow restrictions to determine if interventions like stents are necessary. The gold standard, Fractional Flow Reserve (FFR), involves invasive pressure wires and vasodilator drugs (e.g., adenosine), leading to increased costs, procedural time, and potential complications such as allergic reactions or hemodynamic instability. By contrast, IVUS-FFR integrates intravascular ultrasound imaging with computational fluid dynamics to estimate functional significance without additional devices or medications. This approach could streamline clinical workflows, reduce patient discomfort, and lower healthcare expenses, making it a promising advancement in cardiovascular diagnostics.
- Primary Research Objectives The core goal is to evaluate the diagnostic accuracy of the IVUS-FFR system in identifying hemodynamically significant coronary stenosis, defined as a reduction in blood flow warranting intervention. Using a prospective, multicenter design, the study directly compares IVUS-FFR against FFR as the reference standard. Secondary objectives include assessing feasibility in real-time catheterization lab settings, establishing standardized operational protocols, and refining the technology for broader clinical adoption. Additionally, the study will contrast IVUS-FFR with quantitative coronary angiography (QCA), an anatomical assessment tool, to demonstrate superior diagnostic performance in detecting functionally relevant lesions.
- Study Design and Methodology Overview This research employs a prospective, multicenter, self-controlled clinical trial framework. It targets enrollment of 292 adult participants with suspected or confirmed coronary artery disease, specifically those exhibiting at least one visually estimated coronary stenosis between 30% and 90% diameter reduction. Participants undergo sequential assessments: first, standard coronary angiography and IVUS imaging to generate detailed vascular reconstructions; second, immediate online IVUS-FFR analysis using proprietary algorithms; and third, conventional FFR measurement for validation. Blinding protocols ensure objectivity-IVUS-FFR operators are unaware of FFR results during analysis, and an independent core lab processes QCA data. Statistical methods include receiver operating characteristic (ROC) curves to calculate area under the curve (AUC), sensitivity and specificity analyses, and Delong tests for comparing IVUS-FFR and QCA performance. The sample size provides 90% statistical power to detect a target diagnostic accuracy of 83% for IVUS-FFR.
- Technological Innovations and Workflow Integration The IVUS-FFR system represents a significant leap in computational physiology. It combines high-frequency intravascular ultrasound (40MHz probes) with artificial intelligence-driven segmentation. This involves deep neural networks to automatically delineate vessel structures, such as the lumen and external elastic lamina, enabling precise 3D vascular modeling. Blood flow simulations leverage Murray's law for adaptive hemodynamic calculations, ensuring accurate pressure drop estimations across stenoses. Key innovations include real-time processing capabilities-results are generated within 90 seconds of IVUS data acquisition-and compatibility with existing catheterization lab equipment. This integration minimizes workflow disruptions, adding less than 10 minutes to standard procedures while eliminating the need for pressure wires or vasodilators.
- Participant Eligibility and Ethical Safeguards Eligible participants are adults aged 18 years or older with coronary artery disease symptoms, such as stable or unstable angina, who are scheduled for diagnostic angiography. Exclusion criteria prioritize safety, excluding individuals with recent myocardial infarction (within 72 hours), severe heart failure, significant kidney impairment, pregnancy, or contraindications to iodinated contrast agents. All participants provide informed consent, and the study adheres to stringent ethical oversight through Fuwai Hospital's institutional review board. Rigorous risk mitigation strategies include protocolized management of potential complications like vessel injury during IVUS catheterization and on-site emergency resources for adenosine-related adverse events.
- Expected Outcomes and Broader Implications Upon completion, the study aims to validate IVUS-FFR as a non-inferior alternative to FFR, with anticipated diagnostic accuracy exceeding 83%. This could establish new clinical standards, reducing reliance on invasive FFR and cutting procedural costs by approximately $850 per case. Broader impacts include intellectual property development, such as 2-3 national patents for the core algorithms and 1-2 software copyrights. Dissemination will occur through high-impact publications in Q1-ranked journals and presentations at international conferences, potentially influencing future guidelines on coronary revascularization. If successful, IVUS-FFR could extend to peripheral vascular applications, enhancing patient outcomes globally by enabling faster, safer, and more accessible functional assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVUS-FFR Online Assessment | Experimental | Diagnostic Test: Ultrasound-Derived Fractional Flow Reserve Computational SystemIntervention 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 Exclusion Criteria General Exclusions Contraindications to invasive procedures/FFR per operator judgment Acute myocardial infarction within 72 hours Cardiogenic shock or severe heart failure (NYHA class ≥III or LVEF <30%) Severe renal dysfunction (Creatinine >150 μmol/L or eGFR <45 mL/min/1.73m²) Allergy to iodinated contrast media or adenosine Pregnancy/lactation Life expectancy <1 year Concurrent participation in other interventional trials Angiographic \& IVUS-Specific Exclusions Myocardial bridging at target lesion Severely calcified or tortuous vessels precluding safe IVUS Isolated >90% stenosis with TIMI flow grade <3 in major epicardial artery Other conditions deemed unsuitable for IVUS/FFR by investigators
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Derived Fractional Flow Reserve Computational System1. 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 | Diagnostic test | IVUS-FFR Online Assessment |
Primary outcome
Diagnostic Accuracy of IVUS-FFR in Identifying Hemodynamically Significant Coronary Stenosis
Time frame: Single time point assessment: immediately after IVUS-FFR computation during the index cardiac catheterization procedure.
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.
Diagnostic Accuracy of IVUS-FFR in Identifying Hemodynamically Significant Coronary Stenosis
Time frame: Single assessment at time of index cardiac catheterization procedure.
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%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Results publication: PubMed 26347918Engstrom 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.
- Results publication: PubMed 28317428Smits 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.
- Results publication: PubMed 30596995Zimmermann 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kefei Dou, MD study chair
Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Derived Fractional Flow Reserve Computational System in people with Percutaneous Coronary Intervention and Intravenous Ultrasound, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kefei Dou, Principal Investigator (15980609858, drdoukefei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of IVUS-FFR in Identifying Hemodynamically Significant Coronary Stenosis (time frame: Single time point assessment: immediately after IVUS-FFR computation during the index cardiac catheterization procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07446023, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.