NCT06255678Recruiting
Angio-based Final Functional Effect of PCI
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
Source: ClinicalTrials.gov · Last updated 13 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2005 (estimated)
- First submitted
- 16 Jan 2024
- Start date
- 3 Jul 2023
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Medical University of Warsaw
- Diseases
- Coronary artery disease
- NCT number
- NCT06255678
What you commit to
- Study type: Observational
- Planned participants: 2005
- From 3 Jul 2023 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior coronary artery bypass grafting (CABG)
Other illness
- 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
Other
- Cardiogenic shock, pulmonary oedema
- Severe hemodynamical instability
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Warsaw Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.