RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Charleroi, Belgium, 6042
    • Chu Charleroi
  • Genk, Belgium, 3600
    • Ziekenhuis Oost Limburg
• France
  • Toulouse, France, 50032 31059
    • CHU Toulouse - Hôpital Rangueil
• Slovakia
  • Banska Bystrica, Slovakia, 97401
    • Stredoslovensky ustav srdcovych a cievnych chorob a.s
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801-4421
      • Huntsville Hospital
  • California
    • La Jolla, California, United States, 92037
      • Scripps Green Hospital
    • Riverside, California, United States, 92506-0102
      • Riverside Community Hospital
  • Connecticut
    • Hartford, Connecticut, United States, 06106-5527
      • Hartford Hospital
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Gainesville, Florida, United States, 32605-4524
      • North Florida Regional Medical Center
    • Tallahassee, Florida, United States, 32308-4646
      • Tallahassee Memorial Hospital
  • Georgia
    • Marietta, Georgia, United States, 30060-1125
      • WellStar Kennestone Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5869
      • University of Michigan Health System
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433-4568
      • Mercy Hospital
    • Minneapolis, Minnesota, United States, 55407-1195
      • Abbott Northwestern
  • Nebraska
    • Omaha, Nebraska, United States, 68198-2265
      • Nebraska Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89118-3011
      • Desert Springs Hospital
  • New York
    • East Syracuse, New York, United States, 13057-9208
      • St. Josephs Hospital Health Center
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10032-3729
      • New York-Presbyterian Hospital/ Columbia University Medical Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138-1727
      • Baptist Memorial Hospital-Memphis
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Medical Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Saint Vincent Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Bifurcation Cohort; Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.	Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System; Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Number of Participants With Target Vessel Revascularization (TVR)	Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.	12 months
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
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
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
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

Collaborators and Investigators

• Sponsor: Medtronic Vascular

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Actual): November 4, 2020
• Study Completion (Actual): September 28, 2022

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Ver 4.0 16Feb2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes