RecruitingNCT06255678

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


Sponsor

Medical University of Warsaw

Enrollment

2,005 participants

Start Date

Jul 3, 2023

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Angiography-based vessel fractional flow reserve (vFFR) calculation for people with acute coronary syndrome, chronic coronary syndrome, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTAngiography-based vessel fractional flow reserve (vFFR) calculation

vFFR is calculated from routinely taken angiography images during PCI using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands)


Locations(1)

Medical University of Warsaw

Warsaw, Poland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06255678


Related Trials