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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419521
• Other study ID #: Version 2.0 - 23Mar2015
• Status: Completed
• Phase: N/A
• Start date: July 7, 2015
• Est. completion date: December 3, 2018

Study information

• Verified date: March 2019
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 3, 2018
• Est. primary completion date: July 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Resolute Onyx Stent - 2.25 mm - 4.0 mm

Locations

Country	Name	City	State
United States	AnMed Health Medical Center	Anderson	South Carolina
United States	Morton Plant Hospital	Clearwater	Florida
United States	Dallas VA Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	University Hospitals Elyria Medical Center	Elyria	Ohio
United States	Sanford Medical Center	Fargo	North Dakota
United States	St. Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	Scripps Green Hospital	La Jolla	California
United States	Centennial Medical Center	Nashville	Tennessee
United States	Saint Francis Hospital	Roslyn	New York
United States	Saint John's Hospital	Springfield	Illinois
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 Months
Secondary	Cardiac Death		8 Months
Secondary	Target Vessel Myocardial Infarction (TVMI)		8 Months
Secondary	Target Lesion Revascularization (TLR)		8 Months
Secondary	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	8 Months
Secondary	Target Lesion Failure (TLF)		8 Months
Secondary	Target Vessel Failure (TVF)		8 Months
Secondary	Stent Thrombosis (ST)		8 Months
Secondary	Cardiac Death and TVMI		8 Months