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Functional Coronary Angiography Guided Revascularization in STEMI
Sponsor: University Hospital of Ferrara
Summary
The goal of this multicenter randomized clinical trial is to test the superiority in terms of efficacy of the Angiography-derived fractional flow reserve (AIR) over that based on conventional angiography (ANGIO) strategy in the management of non-culprit lesions in STEMI patients with multivessel disease. The main questions it aims to answer are: * is an Angiography-derived fractional flow reserve strategy superior to a conventional angiography strategy in reducing the occurrence of the composite efficacy endpoint of all-cause death, myocardial infarction, cerebrovascular accident, or ischemia-driven revascularization. * is an Angiography-derived fractional flow reserve strategy superior to a conventional angiography strategy in reducing the occurrence of the composite safety endpoint of of contrast-associated acute kidney injury and Bleeding Academic Research Consortium (BARC) type 3-5. Participants will be randomized after the successful treatment of the culprit lesion to one of the two strategies and prospectively followed-up.
Official title: Functional Coronary Angiography to Indicate and Guide Revascularization in STEMI Patients with Multivessel Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1823
Start Date
2023-05-08
Completion Date
2028-01-31
Last Updated
2025-02-04
Healthy Volunteers
No
Conditions
Interventions
Angiography-guided PCI
Non-culprit lesion treatment will be based on visual estimation by angiography. The evaluation of PCI result will be also based only on angiography.
Angiography-derived FFR PCI indication and planning
Non-culprit lesion treatment will be based on angiography-derived FFR result. In case of positive assessment, PCI will be planned according to the virtual PCI plan based on the physiology pullback curve.
Locations (22)
AUSL Bologna Ospedale Maggiore
Bologna, BO, Italy
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, FE, Italy
Ospedale di Bolzano
Bolzano, Italy, Italy
Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, Italy, Italy
Ospedale Annunziata
Cosenza, Italy, Italy
Ospedale Civile di Baggiovara
Baggiovara, MO, Italy
AUSL Piacenza
Piacenza, PC, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, PR, Italy
Arcispedale Santa Maria Nuova di Reggio Emilia
Reggio Emilia, RE, Italy
AUSL Romagna Ospedale degli Infermi Rimini
Rimini, RN, Italy
Ospedale Santa Maria della Misericordia Rovigo
Rovigo, RO, Italy
Ospedale dell'Angelo Mestre
Mestre, VE, Italy
Ospedale Mater Salutis Legnago
Legnago, VR, Italy
Azienda Ospedaliero Universitaria Integrata di Verona
Verona, VR, Italy
ASST Papa Giovanni XXIII
Bergamo, Italy
AORN Sant'Anna e San Sebastiano
Caserta, Italy
Ospedale Santa Maria Goretti
Latina, Italy
Ospedale Maggiore della Carità Novara
Novara, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
AUSL Romagna Santa Maria delle Croci Ravenna
Ravenna, Italy
Policlinico Casilino
Roma, Italy
NICVD Karachi
Karachi, Pakistan