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Angio-based Final Functional Effect of PCI

Recruitingn/aAges 18 Years - anyAllMedical University of Warsaw
NCT06255678 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 ฮ”vFFR, 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 ฮ”vFFR as prognostic values and indicators of patient health. This is a prospective multicenter register study analyz

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ30ยฐ 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
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What it tests

  • Angiography-based vessel fractional flow reserve (vFFR) calculation
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Where

1 site
Medical University of Warsaw
Warsaw, Poland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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