RESOLUTE ONYX Post-Approval Study (ONYX PAS)

Medtronic

Status: Completed

Conditions: Coronary Artery Disease

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

Study type: Observational

Funder types: Industry

Identifiers

NCT03063749

MDT16025RES003

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.

Enrollment: 416 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

Key Exclusion Criteria

• Unprotected left main disease
• Subjects with planned PCI of three vessel disease

Trial design

416 participants in 2 patient groups

Primary Cohort

Description:

Subjects receiving stents 2.0 mm - 4.0 mm in diameter will be included in the Primary Cohort.

Treatment:

Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Extra Large Vessel (XLV) Cohort.

Description:

Subjects receiving stents 4.5 mm or 5.0 mm in diameter will be included in the Extra Large Vessel (XLV) Cohort.

Treatment:

Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System