RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT03584464
• Lead Sponsor: Medtronic Vascular

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-14
• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-07-12
• Primary Completion: 2020-11-04
• Results First Submitted: 2021-10-29
• Results First Submitted QC: 2021-12-23
• Results First Posted: 2022-01-12
• Study Completion: 2022-09-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Target Vessel Failure (TVF)	12 Months	Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Target Vessel Revascularization (TVR)	12 months	Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.
Number of Participants With Cardiac Death	12 months	Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.
Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI)	Up to 12 months	Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)
Number of Participants With Target Lesion Revascularization (TLR)	12 months	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.
Number of Participants With Target Lesion Failure (TLF)	12 months	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.
Number of Participants With Cardiac Death and TVMI	12 months	Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.
Number of Participants With Major Adverse Cardiac Event (MACE)	12 months	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.
Number of Participants With Stent Thrombosis (ARC) Definite/Probable	12 months	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.

Trial Locations

Locations (25)

Huntsville Hospital; 🇺🇸 Huntsville, Alabama, United States

Scripps Green Hospital; 🇺🇸 La Jolla, California, United States

Riverside Community Hospital; 🇺🇸 Riverside, California, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Morton Plant Hospital; 🇺🇸 Clearwater, Florida, United States

North Florida Regional Medical Center; 🇺🇸 Gainesville, Florida, United States

Tallahassee Memorial Hospital; 🇺🇸 Tallahassee, Florida, United States

WellStar Kennestone Hospital; 🇺🇸 Marietta, Georgia, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

Mercy Hospital; 🇺🇸 Coon Rapids, Minnesota, United States

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