RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

NCT03584464 | Completed Results FDA Device

• 1 other identifier: Ver 4.0 16Feb2018
• Study Type: interventional
• Target: 205
• Locations: 4 countries
• Sites: 25

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of Participants With Cardiac Death

  12 months

• Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI)

  Up to 12 months

• Number of Participants With Target Lesion Revascularization (TLR)

  12 months

• Number of Participants With Target Vessel Revascularization (TVR)

  12 months

• Number of Participants With Cardiac Death and TVMI

  12 months

Study Arms (1)

Bifurcation Cohort

OTHER

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

Interventions

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System DEVICE

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

Bifurcation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (25)

Huntsville Hospital

Huntsville, Alabama, 35801-4421, United States

Location

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Riverside Community Hospital

Riverside, California, 92506-0102, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106-5527, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

North Florida Regional Medical Center

Gainesville, Florida, 32605-4524, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308-4646, United States

Location

WellStar Kennestone Hospital

Marietta, Georgia, 30060-1125, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109-5869, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433-4568, United States

Location

Abbott Northwestern

Minneapolis, Minnesota, 55407-1195, United States

Location

Nebraska Medical Center

Omaha, Nebraska, 68198-2265, United States

Location

Desert Springs Hospital

Las Vegas, Nevada, 89118-3011, United States

Location

St. Josephs Hospital Health Center

East Syracuse, New York, 13057-9208, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

New York-Presbyterian Hospital/ Columbia University Medical Center

New York, New York, 10032-3729, United States

Location

Baptist Memorial Hospital-Memphis

Germantown, Tennessee, 38138-1727, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

Location

Saint Vincent Hospital

Green Bay, Wisconsin, 54301, United States

Location

CHU Charleroi

Charleroi, 6042, Belgium

Location

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

CHU Toulouse - Hôpital Rangueil

Toulouse, 50032 31059, France

Location

Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s

Banská Bystrica, 97401, Slovakia

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Alissa Anderson, Clinical Study Manager
• Organization: Medtronic, plc

alissa.anderson@medtronic.com

7075912434

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: July 12, 2018
• Study Start: May 14, 2018
• Primary Completion: November 4, 2020
• Study Completion: September 28, 2022
• Last Updated: November 24, 2023
• Results First Posted: January 12, 2022

Record last verified: 2023-11

Locations

BE (2); US (21); SL (1); FR (1)