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Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resolute Onyx Stent - 2.25 mm - 4.0 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 (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
  • Must have clinical evidence of ischemic heart disease, stable or unstable angina, and/or a positive functional study
  • Must require treatment of either a) a single target lesion amenable to treatment OR b) two target lesions located in separate target vessels
  • 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
  • Saint Francis Hospital
  • Duke University Medical Center
  • Sanford Medical Center
  • University Hospitals Elyria Medical Center
  • Lankenau Medical Center
  • AnMed Health Medical Center
  • Centennial Medical Center
  • Dallas VA Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Device

Arm Description

Medtronic Resolute Onyx Zotarolimus-Eluting Stent System

Outcomes

Primary Outcome Measures

In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography
In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography

Secondary Outcome Measures

Cardiac Death
Target Vessel Myocardial Infarction (TVMI)
Target Lesion Revascularization (TLR)
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
Target Lesion Failure (TLF)
Target Vessel Failure (TVF)
Stent Thrombosis (ST)
Cardiac Death and TVMI

Full Information

First Posted
April 14, 2015
Last Updated
March 22, 2019
Sponsor
Medtronic Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT02419521
Brief Title
Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study
Official Title
A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 7, 2015 (Actual)
Primary Completion Date
July 5, 2016 (Actual)
Study Completion Date
December 3, 2018 (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 with a reference vessel diameter of 2.25 mm to 4.2 mm.

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
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device
Arm Type
Other
Arm Description
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Intervention Type
Device
Intervention Name(s)
Resolute Onyx Stent - 2.25 mm - 4.0 mm
Primary Outcome Measure Information:
Title
In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography
Description
In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography
Time Frame
8 Months
Secondary Outcome Measure Information:
Title
Cardiac Death
Time Frame
8 Months
Title
Target Vessel Myocardial Infarction (TVMI)
Time Frame
8 Months
Title
Target Lesion Revascularization (TLR)
Time Frame
8 Months
Title
Major Adverse Cardiac Event (MACE)
Description
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
8 Months
Title
Target Lesion Failure (TLF)
Time Frame
8 Months
Title
Target Vessel Failure (TVF)
Time Frame
8 Months
Title
Stent Thrombosis (ST)
Time Frame
8 Months
Title
Cardiac Death and TVMI
Time Frame
8 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 (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery Must have clinical evidence of ischemic heart disease, stable or unstable angina, and/or a positive functional study Must require treatment of either a) a single target lesion amenable to treatment OR b) two target lesions located in separate target vessels 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
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
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
58122
Country
United States
Facility Name
University Hospitals Elyria Medical Center
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
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

12. IPD Sharing Statement

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Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study

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