Acute Coronary SyndromeAFFE-PCINCT06255678
Angio-based Final Functional Effect of PCI
An observational study of Acute Coronary Syndrome and Non ST Segment Elevation Acute Coronary Syndrome, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Fractional flow reserve (FFR) has revolutionized the diagnosis and treatment of coronary artery disease (CAD), and more recently, post percutaneous coronary intervention (post-PCI) FFR has emerged as an independent predictor of cardiovascular events, enabling the identification of cases requiring additional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome, Chronic Coronary Syndrome
- What is being tested?
- Angiography-based vessel fractional flow reserve (vFFR) calculation
- How many people
- 2,005 participants
- Where
- 1 sitePoland
- Study dates
- 3 Jul 2023to 1 Jan 2027
- How long will I take part?
- 2 Years
- 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 with percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS)
Who may be able to join
- Percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS)
- Adequate quality of angiogram enabling vFFR analysis (available two angiographic views with ≥30° differences in rotation/angulation, the possibility of vessel contour selection, proper quality of the images, vessels without severe overlapping, tortuosity, foreshortening and poor vessel opacification)
- Age >18 years
- The patient's written informed consent has been obtained before the procedure
Who cannot join
- Cardiogenic shock, pulmonary oedema
- Severe hemodynamical instability
- Prior coronary artery bypass grafting (CABG)
- Active bleeding
- Acute and chronic inflammatory conditions
- Acute mechanical complications of myocardial infarction
Show all 9Show fewer
- Congenital heart disease
- Heart transplantation
- Non-cardiac comorbidities with a life expectancy of less than 1 year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Karol Sadowski contact
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw, 02-097
Mariusz Tomaniak, MD, PhD, mariusz.tomaniak@wum.edu.pl
About this study
Official title: Angio-based Final Functional Effect of PCI (AFFE PCI): a Prospective Multi-center Study of Post-PCI vFFR Impact on Clinical Outcomes and Residual Angina
Fractional flow reserve (FFR) has revolutionized the diagnosis and treatment of coronary artery disease (CAD), and more recently, post percutaneous coronary intervention (post-PCI) FFR has emerged as an independent predictor of cardiovascular events, enabling the identification of cases requiring additional optimization of the implanted stent. Modern technologies allow less invasive alternatives to traditional FFR measurement - angiography-based vessel fractional flow reserve (vFFR) and derivative ΔvFFR, which is calculated by a difference between the post-PCI vFFR and pre-PCI vFFR. In large clinical studies, the good accuracy between vFFR and FFR - measured before and after PCI - has been confirmed. However, insufficient data is available about the value of post-vFFR and ΔvFFR as prognostic values and indicators of patient health.
This is a prospective multicenter register study analyzing the association between the value of ΔvFFR, vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). Patients undergoing PCI for chronic coronary syndromes (CCS), non-ST-segment elevation acute coronary syndromes (NST-ACS) or ST-Segment Elevation Myocardial Infarction (STEMI) will be enrolled in this study.
Read the detailed description
The primary goal of this prospective multicenter register study is to evaluate the association between the value of vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L) at 6 and 24 months following PCI. The primary composite endpoint is defined as a major adverse cardiovascular event (MACE) including all-cause death, target-vessel myocardial infarction (TVMI), and target vessel revascularization (TVR)] at 6, 12 and 24-month follow-ups. Patients undergoing PCI for chronic coronary syndromes (CCS), non-ST-segment elevation acute coronary syndromes (NST-ACS) or or ST-Segment Elevation Myocardial Infarction (STEMI) will be enrolled in this study. The analyses of the primary endpoint will be stratified according to the following subgroups:
- Diabetes/non-diabetes
- Glomerular filtration rate (GFR)≥60/GFR<60 [ml/min./1,73m2]
- Focal/diffuse atherosclerosis
- Multivessel/single-vessel disease
- CCS/NST-ACS/STEMI
- CCS/ACS
The patients' coronary angiograms will be analyzed using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands) enrolled at the Invasive Cardiology Unit of the 1st Department of Cardiology, Medical University of Warsaw (Poland) and other centers in Poland.
- Conditions
- Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome, Chronic Coronary Syndrome
- Being tested
- Angiography-based vessel fractional flow reserve (vFFR) calculation
- Keywords
- vFFR, ACS, NST-ACS, Angiography-based FFR, Quality of life, Residual angina
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiography-based vessel fractional flow reserve (vFFR) calculationDiagnostic test
vFFR is calculated from routinely taken angiography images during PCI using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands)
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing PCI | Assessment of ΔvFFR and vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L) in patients with CCS or ACS. Receives: Diagnostic Test: Angiography-based vessel fractional flow reserve (vFFR) calculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
Measured: 24 months
Secondary outcomes (21)
Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
Measured: 6 months, 12 months
Rate of all-cause death
Measured: 6 months, 12 months, 24 months
Rate of target-vessel myocardial infarction (TVMI)
Measured: 6 months, 12 months, 24 months
Rate of target-vessel target vessel revascularization (TVR)
Measured: 6 months, 12 months, 24 months
Symptoms of angina and quality of life assessed by the score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L)
The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function.
Measured: 6 months, 12 months, 24 months
Symptoms of angina and quality of life assessed by score of the Seattle Angina Questionnaire (SAQ)
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score.
Measured: 6 months, 12 months, 24 months
Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of Seattle Angina Questionnaire (SAQ).
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. vFFR values are within the range 0-1, where higher values indicate better function.
Measured: 6 months, 12 months, 24 months
Correlation of ΔvFFR with score of Seattle Angina Questionnaire (SAQ).
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score.
Measured: 6 months, 12 months, 24 months
Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L).
The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. vFFR values are within the range 0-1, where higher values indicate better function.
Measured: 6 months, 12 months, 24 months
Correlation of ΔvFFR with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L).
The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function.
Measured: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) for significant prediction of MACE
MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
Measured: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for ΔvFFR useful for prediction of MACE
MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
Measured: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) useful for prediction of higher than median SAQ score.
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. vFFR values are within the range 0-1, where higher values indicate better function.
Measured: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) useful for prediction of higher than median EQ-5D-5L score.
The scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. vFFR values are within the range 0-1, where higher values indicate better function.
Measured: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for ΔvFFR useful for prediction of higher than median SAQ score.
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score.
Measured: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for ΔvFFR useful for prediction of higher than median EQ-5D-5L score.
The scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function.
Measured: 6 months, 12 months, 24 months
Rate of revascularization of any vessel due to exacerbation of angina symptoms.
Decisions on the performance of revascularization will be made by the attending physician according to the clinical features and available methods.
Measured: 6 months, 12 months, 24 months
Rate of definite and probable stent thrombosis.
Measured: 6 months, 12 months, 24 months
Rate of clinically driven invasive coronary angiography due to exacerbation of angina symptoms.
Decisions on the performance of invasive coronary angiography will be made by the attending physician according to the clinical features.
Measured: 6 months, 12 months, 24 months
AUC for the value of in-stent vFFR gradient in predicting the rate of MACE
vFFR values are within the range 0-1, where higher values indicate better function.
Measured: 6 months, 12 months, 24 months
AUC for the value of 3-vessel post-PCI vFFR burden (sum of the vFFR estimated in the three main epicardial arteries) in predicting the rate of MACE
3-vessel post-PCI vFFR will be defined as the sum of the post-PCI vFFR values derived for each vessel (left anterior descending, circumflex, right coronary artery).
Measured: 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start3 Jul 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (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 Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- 2,005 participants (estimated)
- Target duration
- 2 Years
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
- NCT06255678
- Sponsor's protocol ID
- AFFE-PCI
- Acronym
- AFFE-PCI
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tomaniak M, Sadowski K, Bednarek A, Huczek Z, Gierlotka M, Hawranek M, Grabowski M, Wojakowski W, Milewski K, Kochman J. Study design and rationale of the angio-based final functional effect of PCI (AFFE PCI) study: a prospective multi-center study of post-PCI vFFR impact on clinical outcomes and residual angina. Cardiol J. 2024;31(3):488-495. doi: 10.5603/cj.99332. Epub 2024 May 2. No abstract available.
PubMed 38695286
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angio-based Final Functional Effect of PCI (AFFE PCI): a Prospective Multi-center Study of Post-PCI vFFR Impact on Clinical Outcomes and Residual Angina
- ClinicalTrials.gov ID
- NCT06255678
- Acronym / sponsor ID
- AFFE-PCI / AFFE-PCI
- Conditions
- Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome, Chronic Coronary Syndrome
- Keywords
- vFFR, ACS, NST-ACS, Angiography-based FFR, Quality of life, Residual angina
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,005 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 13 Feb 2024 (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.
Fractional flow reserve (FFR) has revolutionized the diagnosis and treatment of coronary artery disease (CAD), and more recently, post percutaneous coronary intervention (post-PCI) FFR has emerged as an independent predictor of cardiovascular events, enabling the identification of cases requiring additional optimization of the implanted stent. Modern technologies allow less invasive alternatives to traditional FFR measurement - angiography-based vessel fractional flow reserve (vFFR) and derivative ΔvFFR, which is calculated by a difference between the post-PCI vFFR and pre-PCI vFFR. In large clinical studies, the good accuracy between vFFR and FFR - measured before and after PCI - has been confirmed. However, insufficient data is available about the value of post-vFFR and ΔvFFR as prognostic values and indicators of patient health.
This is a prospective multicenter register study analyzing the association between the value of ΔvFFR, vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). Patients undergoing PCI for chronic coronary syndromes (CCS), non-ST-segment elevation acute coronary syndromes (NST-ACS) or ST-Segment Elevation Myocardial Infarction (STEMI) will be enrolled in this study.
Detailed description
The primary goal of this prospective multicenter register study is to evaluate the association between the value of vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L) at 6 and 24 months following PCI. The primary composite endpoint is defined as a major adverse cardiovascular event (MACE) including all-cause death, target-vessel myocardial infarction (TVMI), and target vessel revascularization (TVR)] at 6, 12 and 24-month follow-ups. Patients undergoing PCI for chronic coronary syndromes (CCS), non-ST-segment elevation acute coronary syndromes (NST-ACS) or or ST-Segment Elevation Myocardial Infarction (STEMI) will be enrolled in this study. The analyses of the primary endpoint will be stratified according to the following subgroups:
- Diabetes/non-diabetes
- Glomerular filtration rate (GFR)≥60/GFR<60 [ml/min./1,73m2]
- Focal/diffuse atherosclerosis
- Multivessel/single-vessel disease
- CCS/NST-ACS/STEMI
- CCS/ACS
The patients' coronary angiograms will be analyzed using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands) enrolled at the Invasive Cardiology Unit of the 1st Department of Cardiology, Medical University of Warsaw (Poland) and other centers in Poland.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing PCI | – | Diagnostic Test: Angiography-based vessel fractional flow reserve (vFFR) calculationAssessment of ΔvFFR and vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L) in patients with CCS or ACS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS)
Key inclusion criteria (4 listed)
- Percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS)
- Adequate quality of angiogram enabling vFFR analysis (available two angiographic views with ≥30° differences in rotation/angulation, the possibility of vessel contour selection, proper quality of the images, vessels without severe overlapping, tortuosity, foreshortening and poor vessel opacification)
- Age >18 years
- The patient's written informed consent has been obtained before the procedure
Key exclusion criteria (9 listed)
- Cardiogenic shock, pulmonary oedema
- Severe hemodynamical instability
- Prior coronary artery bypass grafting (CABG)
- Active bleeding
- Acute and chronic inflammatory conditions
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 |
|---|---|---|
| Angiography-based vessel fractional flow reserve (vFFR) calculationvFFR is calculated from routinely taken angiography images during PCI using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands) | Diagnostic test | Patients undergoing PCI |
Primary outcome
Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
Time frame: 24 months
21 secondary outcomes
Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
Time frame: 6 months, 12 months
Rate of all-cause death
Time frame: 6 months, 12 months, 24 months
Rate of target-vessel myocardial infarction (TVMI)
Time frame: 6 months, 12 months, 24 months
Rate of target-vessel target vessel revascularization (TVR)
Time frame: 6 months, 12 months, 24 months
Symptoms of angina and quality of life assessed by the score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L)
Time frame: 6 months, 12 months, 24 months
Symptoms of angina and quality of life assessed by score of the Seattle Angina Questionnaire (SAQ)
Time frame: 6 months, 12 months, 24 months
Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of Seattle Angina Questionnaire (SAQ).
Time frame: 6 months, 12 months, 24 months
Correlation of ΔvFFR with score of Seattle Angina Questionnaire (SAQ).
Time frame: 6 months, 12 months, 24 months
Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L).
Time frame: 6 months, 12 months, 24 months
Correlation of ΔvFFR with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L).
Time frame: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) for significant prediction of MACE
Time frame: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for ΔvFFR useful for prediction of MACE
Time frame: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) useful for prediction of higher than median SAQ score.
Time frame: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) useful for prediction of higher than median EQ-5D-5L score.
Time frame: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for ΔvFFR useful for prediction of higher than median SAQ score.
Time frame: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for ΔvFFR useful for prediction of higher than median EQ-5D-5L score.
Time frame: 6 months, 12 months, 24 months
Rate of revascularization of any vessel due to exacerbation of angina symptoms.
Time frame: 6 months, 12 months, 24 months
Rate of definite and probable stent thrombosis.
Time frame: 6 months, 12 months, 24 months
Rate of clinically driven invasive coronary angiography due to exacerbation of angina symptoms.
Time frame: 6 months, 12 months, 24 months
AUC for the value of in-stent vFFR gradient in predicting the rate of MACE
Time frame: 6 months, 12 months, 24 months
AUC for the value of 3-vessel post-PCI vFFR burden (sum of the vFFR estimated in the three main epicardial arteries) in predicting the rate of MACE
Time frame: 6 months, 12 months, 24 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 13 Feb 2024.
- Derived from this study: PubMed 38695286Tomaniak M, Sadowski K, Bednarek A, Huczek Z, Gierlotka M, Hawranek M, Grabowski M, Wojakowski W, Milewski K, Kochman J. Study design and rationale of the angio-based final functional effect of PCI (AFFE PCI) study: a prospective multi-center study of post-PCI vFFR impact on clinical outcomes and residual angina. Cardiol J. 2024;31(3):488-495. doi: 10.5603/cj.99332. Epub 2024 May 2. No abstract available.
- 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.
Karol Sadowski 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 Acute Coronary Syndrome and Non ST Segment Elevation Acute Coronary Syndrome, 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 4 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 13 Feb 2024. 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 (+48 22 5991951, 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?
Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR). (time frame: 24 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 NCT06255678, 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 13 Feb 2024; AzTrials last refreshed its copy on 3 Nov 2026.