NCT06255678

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,005 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Angiography-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)

Timeline

• Start date: 2023-07-03
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2024-02-13
• Last updated: 2024-02-13

Locations

1 site across 1 country: Poland