Coronary Artery DiseaseVISION-FFRNCT06844942
Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve
An observational study of Coronary Artery Disease and Coronary Artery Stenosis, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between mopphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma and a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Stenosis, Tomography, Optical Coherence
- What is being tested?
- vessel Fractional Flow Reserve
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 20 Sep 2020to 31 Jan 2029
- Phase
- Observational
- 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
Study population: Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis.
Who may be able to join
- 18 years or older
- Chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the Canadian Cardiovascular Society classification or positive ischemia test (exercise test, single photon emission tomography (SPECT)
- Intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography and OCT examination The patient is willing to participate in the study and has provided a written informed consent
Who cannot join
- Acute coronary syndrome
- Proximal left main lesion
- Ostial right coronary artery lesion
- Bypass of the assessed vessel
- Contraindications for adenosine administration
- Hemodynamic instability
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- Heart insufficiency in New York Heart Association (NYHA) class IV scale
- Acute renal insufficiency
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Piotr Baruś, MD contact
Poland1 site, 1 recruiting
- Recruiting
1st Department and Clinic of Cardiology, Medical University of Warsaw
Warsaw, Mazowieckie Voivodenship, 02-097
Mariusz Tomaniak, MD, PhD, Assoc. Prof., +48 22 599-19-58, mariusz.tomaniak@wum.edu.pl
Mariusz Tomaniak, MD, PhD, Assoc. Prof.
About this study
The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between mopphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
Read the detailed description
This is a prospective, single center, non-randomized, single-arm, investigator-initiated study evaluating diagnostic accuracy and correlations between morphometric indices: luminal and qualitative parameters evaluated by optical coherence tomography (OCT) including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
The additional objectives encompass assessing the influence of age, sex, diabetes mellitus, renal dysfunction on the relationship between vFFR results and morphometric indices of intermediate coronary stenosis.
We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndrome a positive correlation exists between vFFR and the morphometric parameters associated with coronary stenosis.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Tomography, Optical Coherence, 3D-angio-based FFR
- Being tested
- vessel Fractional Flow Reserve
- 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.
vessel Fractional Flow ReserveDiagnostic test
Optical coherence tomography and vessel fractional flow reserve evaluation of coronary arteries with intermediate to severe stenosis.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing coronary angiogram in chronic coronary syndrome with intermediate stenosis. | Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis. Receives: Diagnostic Test: vessel Fractional Flow Reserve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis
Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis
Measured: 0 days
Secondary outcomes (1)
Major adverse cardiovascular events
Major adverse cardiovascular events
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start20 Sep 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariusz Tomaniak, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844942
- Sponsor's protocol ID
- VISION-FFR
- Acronym
- VISION-FFR
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barus P, Bednarek A, Sadowski K, Sadowski KA, Koltowski L, Rdzanek A, Pietrasik A, Opolski G, Grabowski M, Kochman J, Tomaniak M. Vessel fractional flow reserve (vFFR) vs. optical coherence tomography in chronic coronary syndromes (VISION-FFR). Clin Res Cardiol. 2026 Aug 10. doi: 10.1007/s00392-026-02991-7. Online ahead of print.
PubMed 42573759
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve
- ClinicalTrials.gov ID
- NCT06844942
- Acronym / sponsor ID
- VISION-FFR / VISION-FFR
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Tomography, Optical Coherence, 3D-angio-based FFR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 25 Feb 2025 (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.
The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between mopphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
Detailed description
This is a prospective, single center, non-randomized, single-arm, investigator-initiated study evaluating diagnostic accuracy and correlations between morphometric indices: luminal and qualitative parameters evaluated by optical coherence tomography (OCT) including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
The additional objectives encompass assessing the influence of age, sex, diabetes mellitus, renal dysfunction on the relationship between vFFR results and morphometric indices of intermediate coronary stenosis.
We hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndrome a positive correlation exists between vFFR and the morphometric parameters associated with coronary stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing coronary angiogram in chronic coronary syndrome with intermediate stenosis. | – | Diagnostic Test: vessel Fractional Flow ReservePatients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis.
Key inclusion criteria (3 listed)
- 18 years or older
- Chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the Canadian Cardiovascular Society classification or positive ischemia test (exercise test, single photon emission tomography (SPECT)
- Intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography and OCT examination The patient is willing to participate in the study and has provided a written informed consent
Key exclusion criteria (9 listed)
- Acute coronary syndrome
- Proximal left main lesion
- Ostial right coronary artery lesion
- Bypass of the assessed vessel
- Contraindications for adenosine administration
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 |
|---|---|---|
| vessel Fractional Flow ReserveOptical coherence tomography and vessel fractional flow reserve evaluation of coronary arteries with intermediate to severe stenosis. | Diagnostic test | Patients undergoing coronary angiogram in chronic coronary syndrome with intermediate stenosis. |
Primary outcome
Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis
Time frame: 0 days
Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis
1 secondary outcome
Major adverse cardiovascular events
Time frame: 36 months
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 25 Feb 2025.
- Derived from this study: PubMed 42573759Barus P, Bednarek A, Sadowski K, Sadowski KA, Koltowski L, Rdzanek A, Pietrasik A, Opolski G, Grabowski M, Kochman J, Tomaniak M. Vessel fractional flow reserve (vFFR) vs. optical coherence tomography in chronic coronary syndromes (VISION-FFR). Clin Res Cardiol. 2026 Aug 10. doi: 10.1007/s00392-026-02991-7. Online ahead of print.
- 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.
Piotr Baruś, MD contact
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 Artery Stenosis, run by Medical University of Warsaw at 1 site in Poland.
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 3 inclusion and 9 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 25 Feb 2025. 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 Poland. 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 Mariusz Tomaniak, MD, PhD, Assoc. Prof. (0048225991958, mariusz.tomaniak@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis (time frame: 0 days). 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 NCT06844942, which also lists 1 linked publication.
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 25 Feb 2025.