RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

Medtronic Vascular205 enrolled

Overview

To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population. To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

205

Conditions

Coronary Artery Disease

Interventions

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemDEVICE

Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria * Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation and ST-elevation myocardial infarction * Subject 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 * Subject requires treatment of a single de novo bifurcated lesion amenable to treatment with Resolute Onyx using the provisional stenting technique Exclusion Criteria: * Unprotected left main disease * Subjects with planned PCI of three vessel disease * Planned two stent technique (main branch and side branch) of a bifurcation * Subjects with more than one bifurcation lesion

Locations (25)

Huntsville Hospital

Outcomes

Primary Outcomes

Number of Participants With Target Vessel Failure (TVF)

Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.

Time frame: 12 Months

Secondary Outcomes

Number of Participants With Cardiac Death

Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.

Time frame: 12 months

Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI)

Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)

Time frame: Up to 12 months

Number of Participants With Target Lesion Revascularization (TLR)

Target Lesion Revascularization (TLR) defined as repeat PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Surgery) to the target lesion, or clinically driven target lesion revascularization.

Time frame: 12 months

Number of Participants With Target Vessel Revascularization (TVR)

Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.

Time frame: 12 months

Number of Participants With Cardiac Death and TVMI

Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.

Time frame: 12 months

Number of Participants With Major Adverse Cardiac Event (MACE)

Data from ClinicalTrials.gov

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