Medtronic Resolute Onyx 2.0 mm Clinical Study

Coronary Artery Disease Clinical Trial

Official title:

A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent Resolute Onyx 2.0 mm Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412501
• Other study ID #: Version 5.0 - 26Mar2015
• Status: Completed
• Phase: N/A
• Start date: April 6, 2015
• Est. completion date: February 21, 2019

Study information

• Verified date: June 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 that allows the use of a 2.0 mm diameter stent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 21, 2019
• Est. primary completion date: February 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Resolute Onyx Stent - 2.0 mm
Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent

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	Geisinger Medical Center	Danville	Pennsylvania
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	NYU Langone Medical Center	New York	New York
United States	The Mount Sinai Medical Center	New York	New York
United States	Saint Francis Hospital	Roslyn	New York
United States	Barnes Jewish University	Saint Louis	Missouri
United States	Saint John's Hospital	Springfield	Illinois
United States	East Texas Medical Center	Tyler	Texas
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	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.	12 Months
Secondary	Number of Participants With Cardiac Death at 12 Months Post Procedure		12 Months
Secondary	Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure	TVMI defined as Q Wave or non-Q Wave MI	12 Months
Secondary	Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure		12Months
Secondary	Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure		24 Months
Secondary	Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure		12 Months
Secondary	Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure		12 Months
Secondary	Number of Participants With Cardiac Death at 24 Months Post Procedure		24 Months
Secondary	Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure	TVMI defined as Q Wave or non-Q Wave MI	24 Months
Secondary	Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure		24 Months
Secondary	Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure		24 Months
Secondary	Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure		24 Months
Secondary	Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure		36 Months
Secondary	Number of Participants With Cardiac Death at 36 Months Post Procedure		36 Months
Secondary	Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure	TVMI defined as Q Wave or non-Q Wave MI	36 Months
Secondary	Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure		36 Months
Secondary	Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure		36 Months
Secondary	Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure		36 Months