RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:11/16/2018
Start Date:May 14, 2018
End Date:May 2022
Contact:Alissa Anderson
Email:rs.onyxpas@medtronic.com
Phone:(763) 514-4000

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A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

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.


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
We found this trial at
5
sites
New York, New York 10016
Principal Investigator: Michael Attubato, MD
Phone: 212-263-5656
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Clearwater, Florida 33756
Principal Investigator: Douglas Spriggs, MD
Phone: 727-510-3966
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Clearwater, FL
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La Jolla, California 92037
Principal Investigator: Matthew Price, MD
Phone: 858-554-5032
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La Jolla, CA
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800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Principal Investigator: Yale Wang, MD
Phone: 612-863-3900
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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Nashville, Tennessee 37203
Principal Investigator: Paul Myers, MD
Phone: 615-515-2100
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Nashville, TN
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