Angio-based Final Functional Effect of PCI

NCT06255678 · tracked via the Priya Life Science Poland tracker

Sponsor

Medical University of Warsaw

Phase

Observational

Started

2023-07-03

Last updated

2024-02-13

Condition(s) studied

Acute Coronary SyndromeNon ST Segment Elevation Acute Coronary SyndromeChronic Coronary Syndrome

Investigational drug(s) / intervention(s)

Angiography-based vessel fractional flow reserve (vFFR) calculation

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)

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Congenital heart disease * Heart transplantation * Non-cardiac comorbidities with a life expectancy of less than 1 year

Primary outcome measure(s)

Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR). — 24 months

Trial sites (1)

Facility	City	Region	Status
Medical University of Warsaw	Warsaw	Poland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06255678 on ClinicalTrials.gov ↗ ← All trials in Poland