RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

Medtronic

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03584464

Ver 4.0 16Feb2018

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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205 participants in 1 patient group

Bifurcation Cohort

Other group

Description:

Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.

Treatment:

Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System