Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment resolute onyx stent - 2.0 mm
Sponsor Medtronic Vascular
Start date April 2015
End date April 2017
Trial size 101 participants
Trial identifier NCT02412501, Version 5.0 - 26Mar2015

Summary

The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries that allows the use of a 2.0 mm diameter stent.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent
resolute onyx stent - 2.0 mm
Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent

Primary Outcomes

Measure
Target Lesion Failure
time frame: 12 Months

Secondary Outcomes

Measure
Cardiac Death
time frame: 12 Months
Target Vessel Myocardial Infarction (TVMI)
time frame: 12 Months
Major Adverse Cardiac Event
time frame: 12Months
Target Lesion Failure (TLF)
time frame: 12 Months
Target Vessel Failure (TVF)
time frame: 12 Months
Stent Thrombosis (ST)
time frame: 12 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Must be an acceptable candidate for percutaneous coronary intervention, stenting, & emergent coronary artery bypass graft (CABG) surgery - Must have evidence of ischemic heart disease - Must require treatment of either a) a single target lesion amenable to treatment with a 2.0 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.0 mm study stent - Target lesion(s) must be de novo lesion(s) in native coronary artery(ies) Exclusion Criteria: - Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated - History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative - History of a stroke or transient ischemic attack (TIA) within the prior 6 months - Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months - History of bleeding diathesis or coagulopathy or will refuse blood transfusions - Concurrent medical condition with a life expectancy of less than 12 months - Currently participating in an investigational drug or another device trial that has not completed the primary endpoint - Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation

Additional Information

Official title A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent Resolute Onyx 2.0 mm Clinical Study
Principal investigator Matthew J. Price, MD, FACC, FSCAI
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Medtronic Vascular.