Checking Heart Artery Blood Flow After Stent Placement in Heart Patients
Studies a computer-based blood flow estimate after stent procedures in adults with heart artery disease.
Key facts
- Who runs it
- Medical University of Warsaw
- Where
- Warsaw, PolandSee the site
- Trial code
- Registry title
- Angio-based Final Functional Effect of PCI
- Status
- Recruiting
- People taking part
- 2,005 people, planned
- Started
- 3 Jul 2023
- Expected to end
- 1 Jan 2027
- Type of study
- Observational
- Treatments tested
- Angiography-based vessel fractional flow reserve (vFFR) calculation
- Record updated
- 13 February 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are having a stent procedure (PCI) for long-term or sudden coronary artery disease and have good-quality heart X-ray images.
- Age
- Older than 18 years
- Sex
- All sexes can join.
- Disease stage
- Chronic coronary syndromes or acute coronary syndromes, treated with a stent procedure (PCI).
- Earlier treatment
- No earlier coronary artery bypass surgery (CABG).
- Biomarker or test result
- Heart X-ray images (angiogram) of good enough quality to calculate vFFR: two views at least 30° apart, with no severe overlap, twisting or poor filling of the vessel.
Main reasons for not taking part
- Cardiogenic shock or fluid in the lungs (pulmonary oedema)
- Severe unstable blood circulation
- Active bleeding
- Acute or chronic inflammatory conditions
- Heart transplant, congenital heart disease, or a life expectancy of less than 1 year
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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 take part
- Prior coronary artery bypass grafting (CABG)
- Active bleeding
- Acute and chronic inflammatory conditions
- Acute mechanical complications of myocardial infarction
- Congenital heart disease
- Heart transplantation
- Non-cardiac comorbidities with a life expectancy of less than 1 year
- Cardiogenic shock, pulmonary oedema
- Severe hemodynamical instability
Where in Poland
- Medical University of WarsawWarsaw, PolandContact: Mariusz Tomaniak, MD, PhDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- 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.
Treatment: Angiography-based vessel fractional flow reserve (vFFR) calculation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Checking Heart Artery Blood Flow After Stent Placement in Heart PatientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 13 February 2024