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

NCT02419521 | Completed Results DMC

• 1 other identifier: Version 2.0 - 23Mar2015
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 12

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Cardiac Death

  8 Months

• Target Vessel Myocardial Infarction (TVMI)

  8 Months

• Target Lesion Revascularization (TLR)

  8 Months

• Major Adverse Cardiac Event (MACE)

  8 Months

• Target Lesion Failure (TLF)

  8 Months

Study Arms (1)

Device

OTHER

Medtronic Resolute Onyx Zotarolimus-Eluting Stent System

Device: Resolute Onyx Stent - 2.25 mm - 4.0 mm

Interventions

Resolute Onyx Stent - 2.25 mm - 4.0 mm DEVICE

Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (12)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Saint John's Hospital

Springfield, Illinois, 62701, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

Location

Saint Francis Hospital

Roslyn, New York, 11576, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Sanford Medical Center

Fargo, North Dakota, 58122, United States

Location

University Hospitals Elyria Medical Center

Elyria, Ohio, 44035, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

AnMed Health Medical Center

Anderson, South Carolina, 29621, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37205, United States

Location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Beth Moe, Clinical Study Manager
• Organization: Medtronic Coronary Structual Heart

beth.moe@medtronic.com

Study Officials

• Matthew J. Price, MD, FACC, FSCAI

  Scripps Green Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 17, 2015
• Study Start: July 7, 2015
• Primary Completion: July 5, 2016
• Study Completion: December 3, 2018
• Last Updated: April 3, 2019
• Results First Posted: July 28, 2017

Record last verified: 2019-03

Locations

US (12)