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RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Sponsored by
Medtronic Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Huntsville Hospital
  • Scripps Green Hospital
  • Riverside Community Hospital
  • Hartford Hospital
  • Morton Plant Hospital
  • North Florida Regional Medical Center
  • Tallahassee Memorial Hospital
  • WellStar Kennestone Hospital
  • University of Michigan Health System
  • Mercy Hospital
  • Abbott Northwestern
  • Nebraska Medical Center
  • Desert Springs Hospital
  • St. Josephs Hospital Health Center
  • North Shore University Hospital
  • NYU Langone Medical Center
  • New York-Presbyterian Hospital/ Columbia University Medical Center
  • Baptist Memorial Hospital-Memphis
  • Houston Methodist Hospital
  • University of Virginia Medical Center
  • Saint Vincent Hospital
  • CHU Charleroi
  • Ziekenhuis Oost Limburg
  • CHU Toulouse - Hôpital Rangueil
  • Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Bifurcation Cohort

Arm Description

Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Cardiac Death
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)
Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)
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.
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.
Number of Participants With Cardiac Death and TVMI
Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.
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.
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.
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.

Full Information

First Posted
May 14, 2018
Last Updated
October 6, 2023
Sponsor
Medtronic Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT03584464
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
November 4, 2020 (Actual)
Study Completion Date
September 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bifurcation Cohort
Arm Type
Other
Arm Description
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Intervention Type
Device
Intervention Name(s)
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Intervention Description
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm
Primary Outcome Measure Information:
Title
Number of Participants With Target Vessel Failure (TVF)
Description
Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Number of Participants With Cardiac Death
Description
Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.
Time Frame
12 months
Title
Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI)
Description
Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)
Time Frame
Up to 12 months
Title
Number of Participants With Target Lesion Revascularization (TLR)
Description
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.
Time Frame
12 months
Title
Number of Participants With Target Vessel Revascularization (TVR)
Description
Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.
Time Frame
12 months
Title
Number of Participants With Cardiac Death and TVMI
Description
Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.
Time Frame
12 months
Title
Number of Participants With Major Adverse Cardiac Event (MACE)
Description
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.
Time Frame
12 months
Title
Number of Participants With Target Lesion Failure (TLF)
Description
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.
Time Frame
12 months
Title
Number of Participants With Stent Thrombosis (ARC) Definite/Probable
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Huntsville Hospital
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801-4421
Country
United States
Facility Name
Scripps Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Riverside Community Hospital
City
Riverside
State/Province
California
ZIP/Postal Code
92506-0102
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106-5527
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
North Florida Regional Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605-4524
Country
United States
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308-4646
Country
United States
Facility Name
WellStar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060-1125
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5869
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433-4568
Country
United States
Facility Name
Abbott Northwestern
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407-1195
Country
United States
Facility Name
Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2265
Country
United States
Facility Name
Desert Springs Hospital
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89118-3011
Country
United States
Facility Name
St. Josephs Hospital Health Center
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057-9208
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York-Presbyterian Hospital/ Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Facility Name
Baptist Memorial Hospital-Memphis
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138-1727
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Saint Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
CHU Charleroi
City
Charleroi
ZIP/Postal Code
6042
Country
Belgium
Facility Name
Ziekenhuis Oost Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
CHU Toulouse - Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
50032 31059
Country
France
Facility Name
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
City
Banska Bystrica
ZIP/Postal Code
97401
Country
Slovakia

12. IPD Sharing Statement

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RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

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