Clinical trial NCT03584464: RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)
Official title: A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2018-07-12
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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
* 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

Primary outcomes:
measure: Number of Participants With Target Vessel Failure (TVF)
timeFrame: 12 Months
Secondary outcomes:
measure: Number of Participants With Cardiac Death
timeFrame: 12 months
measure: Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI)
timeFrame: Up to 12 months
measure: Number of Participants With Target Lesion Revascularization (TLR)
timeFrame: 12 months
measure: Number of Participants With Target Vessel Revascularization (TVR)
timeFrame: 12 months
measure: Number of Participants With Cardiac Death and TVMI
timeFrame: 12 months
measure: Number of Participants With Major Adverse Cardiac Event (MACE)
timeFrame: 12 months
measure: Number of Participants With Target Lesion Failure (TLF)
timeFrame: 12 months
measure: Number of Participants With Stent Thrombosis (ARC) Definite/Probable
timeFrame: 12 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Huntsville Hospital
state: Alabama
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Riverside
country: United States
facility: Riverside Community Hospital
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Marietta
country: United States
facility: WellStar Kennestone Hospital
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott Northwestern
state: Minnesota
city: Omaha
country: United States
facility: Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Desert Springs Hospital
state: Nevada
city: East Syracuse
country: United States
facility: St. Josephs Hospital Health Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/ Columbia University Medical Center
state: New York
city: Germantown
country: United States
facility: Baptist Memorial Hospital-Memphis
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Green Bay
country: United States
facility: Saint Vincent Hospital
state: Wisconsin
city: Charleroi
country: Belgium
facility: CHU Charleroi
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Rangueil
city: Banska Bystrica
country: Slovakia
facility: Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
Study officials:
References: