Coronary Artery DiseaseV-IVUS_FFRNCT07551518
Retrospective Algorithm Validation of IVUS-FFR in Patients
An observational study of Coronary Artery Disease and Coronary Stenosis, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis, Algorithm Validation for Fractional Flow Reserve Derived From Intravascular Ultrasound
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 30 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: This retrospective study includes approximately 100 adult patients with suspected or known coronary artery disease who underwent clinically indicated invasive coronary angiography, intravascular ultrasound (IVUS) imaging, and fractional flow reserve (FFR) measurement at Fuwai Hospital. The cohort consists of patients with intermediate coronary lesions (30-90% diameter stenosis by visual estimation) for whom both anatomical assessment by IVUS and physiological assessment by FFR were deemed clinically necessary. Data were collected from existing medical records and imaging archives, and all personal identifiers have been removed prior to analysis.
Who may be able to join
- 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%.
Who cannot join
- Chronic total occlusion (CTO) of the target vessel.
- Prior coronary artery bypass grafting (CABG) involving the target vessel.
- IVUS pullback did not cover the entire lesion.
- Severe myocardial bridge or vessel spasm in the interrogated vessel.
- Substantial thrombosis or dissection identified by IVUS.
- Image quality deemed inadequate for analysis by two independent analysts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Algorithm Development and Validation of Intravascular Ultrasound-Derived Fractional Flow Reserve (IvusFFR): A Single-Center Study in Patients
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.
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Algorithm Validation for Fractional Flow Reserve Derived From Intravascular Ultrasound
- Being tested
- No Intervention (Retrospective Data Analysis)
- Keywords
- Intravascular Ultrasound, Fractional Flow Reserve, Computational Physiology, Algorithm Development
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention (Retrospective Data Analysis)Other
This is a retrospective observational study. No prospective intervention is administered. Participants' existing IVUS images and FFR measurements are analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective IVUS-FFR Cohort | This single retrospective cohort consists of approximately 100 patients who underwent clinically indicated coronary angiography, intravascular ultrasound (IVUS) imaging, and invasive fractional flow reserve (FFR) measurement at Fuwai Hospital. All data were collected as part of routine clinical care and have been fully anonymized prior to analysis. The cohort includes both pre- and post-percutaneous coronary intervention (PCI) pullbacks where available. No prospective intervention or patient contact is involved. The dataset is used for algorithm development and validation of IvusFFR v2.0, a software for computing FFR from IVUS images. Receives: Other: No Intervention (Retrospective Data Analysis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of IvusFFR v2.0 for Identifying Hemodynamically Significant Coronary Stenosis
Diagnostic accuracy of IvusFFR v2.0 in identifying hemodynamically significant coronary stenosis, using wire-based fractional flow reserve (FFR) ≤0.80 as the reference standard. Accuracy is defined as (True Positive + True Negative) / (Total Number of Vessels).
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Dec 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551518
- Sponsor's protocol ID
- 2024-2321
- Acronym
- V-IVUS_FFR
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30596995Yu W, Tanigaki T, Ding D, Wu P, Du H, Ling L, Huang B, Li G, Yang W, Zhang S, Yan F, Okubo M, Xu B, Matsuo H, Wijns W, Tu S. Accuracy of Intravascular Ultrasound-Based Fractional Flow Reserve in Identifying Hemodynamic Significance of Coronary Stenosis. Circ Cardiovasc Interv. 2021 Feb;14(2):e009840. doi: 10.1161/CIRCINTERVENTIONS.120.009840. Epub 2021 Feb 5.
PubMed 33541105
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Algorithm Development and Validation of Intravascular Ultrasound-Derived Fractional Flow Reserve (IvusFFR): A Single-Center Study in Patients
- ClinicalTrials.gov ID
- NCT07551518
- Acronym / sponsor ID
- V-IVUS_FFR / 2024-2321
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Algorithm Validation for Fractional Flow Reserve Derived From Intravascular Ultrasound
- Keywords
- Intravascular Ultrasound, Fractional Flow Reserve, Computational Physiology, Algorithm Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 27 Apr 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective IVUS-FFR Cohort | – | Other: No Intervention (Retrospective Data Analysis)This single retrospective cohort consists of approximately 100 patients who underwent clinically indicated coronary angiography, intravascular ultrasound (IVUS) imaging, and invasive fractional flow reserve (FFR) measurement at Fuwai Hospital. All data were collected as part of routine clinical care and have been fully anonymized prior to analysis. The cohort includes both pre- and post-percutaneous coronary intervention (PCI) pullbacks where available. No prospective intervention or patient contact is involved. The dataset is used for algorithm development and validation of IvusFFR v2.0, a software for computing FFR from IVUS images. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study includes approximately 100 adult patients with suspected or known coronary artery disease who underwent clinically indicated invasive coronary angiography, intravascular ultrasound (IVUS) imaging, and fractional flow reserve (FFR) measurement at Fuwai Hospital. The cohort consists of patients with intermediate coronary lesions (30-90% diameter stenosis by visual estimation) for whom both anatomical assessment by IVUS and physiological assessment by FFR were deemed clinically necessary. Data were collected from existing medical records and imaging archives, and all personal identifiers have been removed prior to analysis.
Key inclusion criteria (5 listed)
- 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%.
Key exclusion criteria (6 listed)
- Chronic total occlusion (CTO) of the target vessel.
- Prior coronary artery bypass grafting (CABG) involving the target vessel.
- IVUS pullback did not cover the entire lesion.
- Severe myocardial bridge or vessel spasm in the interrogated vessel.
- Substantial thrombosis or dissection identified by IVUS.
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 |
|---|---|---|
| No Intervention (Retrospective Data Analysis)This is a retrospective observational study. No prospective intervention is administered. Participants' existing IVUS images and FFR measurements are analyzed. | Other | Retrospective IVUS-FFR Cohort |
Primary outcome
Diagnostic Accuracy of IvusFFR v2.0 for Identifying Hemodynamically Significant Coronary Stenosis
Time frame: Through study completion, an average of 6 months
Diagnostic accuracy of IvusFFR v2.0 in identifying hemodynamically significant coronary stenosis, using wire-based fractional flow reserve (FFR) ≤0.80 as the reference standard. Accuracy is defined as (True Positive + True Negative) / (Total Number of Vessels).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 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.
- Results publication: PubMed 33541105Yu W, Tanigaki T, Ding D, Wu P, Du H, Ling L, Huang B, Li G, Yang W, Zhang S, Yan F, Okubo M, Xu B, Matsuo H, Wijns W, Tu S. Accuracy of Intravascular Ultrasound-Based Fractional Flow Reserve in Identifying Hemodynamic Significance of Coronary Stenosis. Circ Cardiovasc Interv. 2021 Feb;14(2):e009840. doi: 10.1161/CIRCINTERVENTIONS.120.009840. Epub 2021 Feb 5.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Stenosis, 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 27 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of IvusFFR v2.0 for Identifying Hemodynamically Significant Coronary Stenosis (time frame: Through study completion, an average of 6 months). 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 NCT07551518, which also lists 4 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 27 Apr 2026.