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Medtronic Resolute Onyx 2.0 mm Clinical Study

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resolute Onyx Stent - 2.0 mm
Sponsored by
Medtronic Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Must be an acceptable candidate for percutaneous coronary intervention, stenting, & emergent coronary artery bypass graft (CABG) surgery
  • Must have evidence of ischemic heart disease
  • Must require treatment of either a) a single target lesion amenable to treatment with a 2.0 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.0 mm study stent
  • Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)

Exclusion Criteria:

  • Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
  • History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
  • History of a stroke or transient ischemic attack (TIA) within the prior 6 months
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
  • History of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Concurrent medical condition with a life expectancy of less than 12 months
  • Currently participating in an investigational drug or another device trial that has not completed the primary endpoint
  • Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation

Sites / Locations

  • Scripps Green Hospital
  • Morton Plant Hospital
  • Saint John's Hospital
  • St. Vincent Heart Center of Indiana
  • Barnes Jewish University
  • NYU Langone Medical Center
  • The Mount Sinai Medical Center
  • Saint Francis Hospital
  • Duke University Medical Center
  • Sanford Medical Center
  • University Hospitals Elyria Medical Center
  • Geisinger Medical Center
  • Lankenau Medical Center
  • AnMed Health Medical Center
  • Centennial Medical Center
  • Dallas VA Medical Center
  • East Texas Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Device

Arm Description

Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent

Outcomes

Primary Outcome Measures

Number of Participants With Target Lesion Failure at 12 Months Post-Procedure
Target Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods.

Secondary Outcome Measures

Number of Participants With Cardiac Death at 12 Months Post Procedure
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure
TVMI defined as Q Wave or non-Q Wave MI
Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure
Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure
Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure
Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure
Number of Participants With Cardiac Death at 24 Months Post Procedure
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure
TVMI defined as Q Wave or non-Q Wave MI
Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure
Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure
Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure
Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure
Number of Participants With Cardiac Death at 36 Months Post Procedure
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure
TVMI defined as Q Wave or non-Q Wave MI
Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure
Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure
Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure

Full Information

First Posted
April 6, 2015
Last Updated
June 11, 2019
Sponsor
Medtronic Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT02412501
Brief Title
Medtronic Resolute Onyx 2.0 mm Clinical Study
Official Title
A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent Resolute Onyx 2.0 mm Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 6, 2015 (Actual)
Primary Completion Date
February 13, 2017 (Actual)
Study Completion Date
February 21, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries that allows the use of a 2.0 mm diameter stent.

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device
Arm Type
Other
Arm Description
Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent
Intervention Type
Device
Intervention Name(s)
Resolute Onyx Stent - 2.0 mm
Intervention Description
Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
Primary Outcome Measure Information:
Title
Number of Participants With Target Lesion Failure at 12 Months Post-Procedure
Description
Target Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Number of Participants With Cardiac Death at 12 Months Post Procedure
Time Frame
12 Months
Title
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure
Description
TVMI defined as Q Wave or non-Q Wave MI
Time Frame
12 Months
Title
Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure
Time Frame
12Months
Title
Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure
Time Frame
24 Months
Title
Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure
Time Frame
12 Months
Title
Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure
Time Frame
12 Months
Title
Number of Participants With Cardiac Death at 24 Months Post Procedure
Time Frame
24 Months
Title
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure
Description
TVMI defined as Q Wave or non-Q Wave MI
Time Frame
24 Months
Title
Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure
Time Frame
24 Months
Title
Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure
Time Frame
24 Months
Title
Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure
Time Frame
24 Months
Title
Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure
Time Frame
36 Months
Title
Number of Participants With Cardiac Death at 36 Months Post Procedure
Time Frame
36 Months
Title
Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure
Description
TVMI defined as Q Wave or non-Q Wave MI
Time Frame
36 Months
Title
Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure
Time Frame
36 Months
Title
Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure
Time Frame
36 Months
Title
Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure
Time Frame
36 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be an acceptable candidate for percutaneous coronary intervention, stenting, & emergent coronary artery bypass graft (CABG) surgery Must have evidence of ischemic heart disease Must require treatment of either a) a single target lesion amenable to treatment with a 2.0 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.0 mm study stent Target lesion(s) must be de novo lesion(s) in native coronary artery(ies) Exclusion Criteria: Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative History of a stroke or transient ischemic attack (TIA) within the prior 6 months Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months History of bleeding diathesis or coagulopathy or will refuse blood transfusions Concurrent medical condition with a life expectancy of less than 12 months Currently participating in an investigational drug or another device trial that has not completed the primary endpoint Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J. Price, MD, FACC, FSCAI
Organizational Affiliation
Scripps Green Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shigeru Saito, MD
Organizational Affiliation
Shonan Kamakura General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Saint John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
St. Vincent Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Barnes Jewish University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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
The Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Saint Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Sanford Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Facility Name
University Hospitals Elyria Medical Center
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
AnMed Health Medical Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
East Texas Medical Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28728650
Citation
Price MJ, Saito S, Shlofmitz RA, Spriggs DJ, Attubato M, McLaurin B, Popma Almonacid A, Brar S, Liu M, Moe E, Mehran R. First Report of the Resolute Onyx 2.0-mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions With Very Small Reference Vessel Diameter. JACC Cardiovasc Interv. 2017 Jul 24;10(14):1381-1388. doi: 10.1016/j.jcin.2017.05.004.
Results Reference
derived

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Medtronic Resolute Onyx 2.0 mm Clinical Study

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