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ACTIVE NOT RECRUITING
NCT05818475
NA

Functional Coronary Angiography Guided Revascularization in STEMI

Sponsor: University Hospital of Ferrara

View on ClinicalTrials.gov

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

Interventions

OTHER

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.

OTHER

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