Coronary Artery Disease
Conditions
Brief summary
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.
Detailed description
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
Interventions
DEVICEResolute Onyx
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
Sponsors
University of Padova
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Subject \> 18 years old * ULMCAD with angiographic diameter stenosis \>50% (if 50-70% evidence of FFR \<0.80 or IVUS minimal lumen area \<6.0 mm2 is recommended. * Silent ischemia, stable angina, unstable angina or non-ST elevation myocardial infarction * Ability to provide written informed consent and comply with follow-up for at least 2 years.
Exclusion criteria
1. Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| target lesion failure | 12 months | composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization |
Countries
Italy, Portugal
Outcome results
None listed