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

Status: Active, not recruiting
Location: See all (25) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
Alabama
Huntsville Hospital
Huntsville
California
Scripps Green Hospital
La Jolla
Riverside Community Hospital
Riverside
Connecticut
Hartford Hospital
Hartford
Florida
Morton Plant Hospital
Clearwater
North Florida Regional Medical Center
Gainesville
Tallahassee Memorial Hospital
Tallahassee
Georgia
WellStar Kennestone Hospital
Marietta
Michigan
University of Michigan Health System
Ann Arbor
Minnesota
Mercy Hospital
Coon Rapids
Abbott Northwestern
Minneapolis
Nebraska
Nebraska Medical Center
Omaha
Nevada
Desert Springs Hospital
Las Vegas
New York
St. Josephs Hospital Health Center
East Syracuse
North Shore University Hospital
Manhasset
New York-Presbyterian Hospital/ Columbia University Medical Center
New York
NYU Langone Medical Center
New York
Tennessee
Baptist Memorial Hospital-Memphis
Germantown
Texas
Houston Methodist Hospital
Houston
Virginia
University of Virginia Medical Center
Charlottesville
Wisconsin
Saint Vincent Hospital
Green Bay
Other Locations
Belgium
CHU Charleroi
Charleroi
Ziekenhuis Oost Limburg
Genk
France
CHU Toulouse - Hôpital Rangueil
Toulouse
Slovakia
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
Banska Bystrica
Time Frame
Start Date: May 14, 2018
Estimated Completion Date: January 2023
Participants
Target number of participants: 205
Treatments
Other: Bifurcation Cohort
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Sponsors
Leads: Medtronic Vascular

This content was sourced from clinicaltrials.gov