RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584464
• Other study ID #: Ver 4.0 16Feb2018
• Status: Completed
• Phase: N/A
• Start date: May 14, 2018
• Est. completion date: September 28, 2022

Study information

• Verified date: November 2023
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: September 28, 2022
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm

Locations

Country	Name	City	State
Belgium	CHU Charleroi	Charleroi
Belgium	Ziekenhuis Oost Limburg	Genk
France	CHU Toulouse - Hôpital Rangueil	Toulouse
Slovakia	Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s	Banska Bystrica
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Morton Plant Hospital	Clearwater	Florida
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	St. Josephs Hospital Health Center	East Syracuse	New York
United States	North Florida Regional Medical Center	Gainesville	Florida
United States	Baptist Memorial Hospital-Memphis	Germantown	Tennessee
United States	Saint Vincent Hospital	Green Bay	Wisconsin
United States	Hartford Hospital	Hartford	Connecticut
United States	Houston Methodist Hospital	Houston	Texas
United States	Huntsville Hospital	Huntsville	Alabama
United States	Scripps Green Hospital	La Jolla	California
United States	Desert Springs Hospital	Las Vegas	Nevada
United States	North Shore University Hospital	Manhasset	New York
United States	WellStar Kennestone Hospital	Marietta	Georgia
United States	Abbott Northwestern	Minneapolis	Minnesota
United States	New York-Presbyterian Hospital/ Columbia University Medical Center	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Nebraska Medical Center	Omaha	Nebraska
United States	Riverside Community Hospital	Riverside	California
United States	Tallahassee Memorial Hospital	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Countries where clinical trial is conducted

United States,  Belgium,  France,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Target Vessel Failure (TVF)	Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.	12 Months
Secondary	Number of Participants With Cardiac Death	Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.	12 months
Secondary	Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI)	Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)	Up to 12 months
Secondary	Number of Participants With Target Lesion Revascularization (TLR)	Target Lesion Revascularization (TLR) defined as repeat PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Surgery) to the target lesion, or clinically driven target lesion revascularization.	12 months
Secondary	Number of Participants With Target Vessel Revascularization (TVR)	Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.	12 months
Secondary	Number of Participants With Cardiac Death and TVMI	Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.	12 months
Secondary	Number of Participants With Major Adverse Cardiac Event (MACE)	Major Adverse Cardiac Event (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically driven repeat target lesion revascularization by percutaneous or surgical methods.	12 months
Secondary	Number of Participants With Target Lesion Failure (TLF)	Target Lesion Failure (TLF) defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods.	12 months
Secondary	Number of Participants With Stent Thrombosis (ARC) Definite/Probable	Stent Thrombosis Definite/Probable defined per Academic Research Consortium (ARC).; Definite: a. Angiographic confirmation of TIMI flow grade 0-3 and at least one of the following criteria within a 48 hour: 1.New onset s ischemic symptoms at rest (typical chest pain with duration >20 minutes); 2.New ischemic ECG changes suggestive of acute ischemia; 3.Typical rise and fall in cardiac biomarkers. or b. Pathologic confirmation of stent thrombosis: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.; Probable: Any unexplained death within the first 30 days.	12 months