Angio-based Final Functional Effect of PCI

Recruiting now

Conditions studied: Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome, Chronic Coronary Syndrome

In brief

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.

Key facts

Study ID

NCT06255678

Run by

Medical University of Warsaw

People needed

2005

Starts

2023-07-03

Expected to finish

2027-01-01

Last updated by the study team

2024-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical University of Warsaw — Warsaw, Poland (enrolling)

Full record on ClinicalTrials.gov

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