Medtronic Resolute Onyx 2.0 mm Clinical Study

NCT02412501 | Completed Results DMC

• 1 other identifier: Version 5.0 - 26Mar2015
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 17

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Number of Participants With Cardiac Death at 12 Months Post Procedure

  12 Months

• Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure

  12 Months

• Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure

  12Months

• Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure

  24 Months

• Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure

  12 Months

Study Arms (1)

Device

OTHER

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

Device: Resolute Onyx Stent - 2.0 mm

Interventions

Resolute Onyx Stent - 2.0 mm DEVICE

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

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, 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)

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 (17)

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

Barnes Jewish University

St Louis, Missouri, 63110, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

The Mount Sinai Medical Center

New York, New York, 10029, 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, 58102, United States

Location

University Hospitals Elyria Medical Center

Elyria, Ohio, 44035, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, 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

East Texas Medical Center

Tyler, Texas, 75701, United States

Location

Related Publications (1)

• 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.

  PMID: 28728650 DERIVED

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/Structural Heart

beth.moe@medtronic.com

763-526-1184

Study Officials

• Matthew J. Price, MD, FACC, FSCAI

  Scripps Green Hospital

  PRINCIPAL INVESTIGATOR

• Shigeru Saito, MD

  Shonan Kamakura General 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 6, 2015
• First Posted: April 9, 2015
• Study Start: April 6, 2015
• Primary Completion: February 13, 2017
• Study Completion: February 21, 2019
• Last Updated: July 2, 2019
• Results First Posted: April 10, 2018

Record last verified: 2019-06

Locations

US (17)