The primary objective of this study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent Resolute Onyx in the treatment of unprotected left main coronary artery disease (ULMCAD), both isolated or in association with two- or three-vessel coronary artery disease.
The ROLEX study is a prospective, non-randomized, European, multi-center registry. Four hundred and fifty patients with unprotected left main coronary artery disease (ULMCAD) will be enrolled at up to 40 European sites. The main objective of the study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent Resolute Onyx in the treatment of ULMCAD, both isolated or in association with two- or three-vessel coronary artery disease
Study Type
OBSERVATIONAL
Enrollment
450
Percutaneous coronary revascularization of patients with unprotected left main coronary artery disease up to intermediate anatomical complexity (defined by a SYNTAX score \<33), must be performed with the exclusive use of drug-eluting stents of the Resolute Onyx TM family
target lesion failure
composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization
Time frame: 12 months
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Azienda Ospedale Università Padova
Padua, PD, Italy
ASP 1 Agrigento - Ospedale San Giovanni di Dio
Agrigento, Italy
Policlinico San Donato
Arezzo, Italy
Azienda Ospedaliera S.Anna e S.Sebastiano
Caserta, Italy
Ospedale Ferrarotto
Catania, Italy
Ospedale civile dell'Annunziata
Cosenza, Italy
Azienda Socio-Sanitaria Territoriale di Cremona
Cremona, Italy
Ospedale Santa Croce e Carle
Cuneo, Italy
Azienda Ospedaliera Grosseto
Grosseto, Italy
Ospedale Fazzi
Lecce, Italy
...and 23 more locations