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 |
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.
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
800 E 28th St
Minneapolis, Minnesota 55407
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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Clearwater, Florida 33756
Principal Investigator: Douglas Spriggs, MD
Phone: 727-510-3966
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La Jolla, California 92037
Principal Investigator: Matthew Price, MD
Phone: 858-554-5032
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Nashville, Tennessee 37203
Principal Investigator: Paul Myers, MD
Phone: 615-515-2100
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New York, New York 10016
Principal Investigator: Michael Attubato, MD
Phone: 212-263-5656
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