This prospective, multicenter, non-randomized, single arm, objective performance goal (OPG) study is designed to evaluate clinical outcomes after complete revascularization by PCI and imaging guidance (OCT) in patients with multivessel coronary artery disease including left anterior descending (LAD) presenting with stable angina, or documented silent ischemia, or non-ST segment elevation acute coronary syndrome (NSTE-ACS).
Age ≥ 18 years, ≤85 years
The patient is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki
Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Instructions for Use' that comes with every Resolute Onyx (Zotarolimus-Eluting stent) system.
The patient is willing and able to cooperate with study procedures and required follow up visits
Age <18 years and > 85 years.
Single coronary vessel disease.
No left anterior descending lesion.
Patients in cardiogenic shock.
Single group
PCI with OCT guidance
DeviceProcedure will be optimize using pre-and post-stent OCT imaging, to improve the accuracy of stent placement and reduce geographic miss, but also to prevent malapposition of the stent and to discover dissections.
MACCE- 1 year
The primary clinical endpoint of this study is a composite of death from any cause, stroke, myocardial infarction, or unplanned ischemia driven repeat revascularization at 1-year post index procedure.
MACCE
Composite of death from any cause, stroke, myocardial infarction, or repeat revascularization
All-cause mortality
All-cause mortality
Myocardial Infarction
Myocardial Infarction
Any revascularization
Any revascularization
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