Clinical trial NCT02412501: Medtronic Resolute Onyx 2.0 mm Clinical Study
Official title: A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent Resolute Onyx 2.0 mm Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2015-04-09
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Target Lesion Failure at 12 Months Post-Procedure
timeFrame: 12 Months
Secondary outcomes:
measure: Number of Participants With Cardiac Death at 12 Months Post Procedure
timeFrame: 12 Months
measure: Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure
timeFrame: 12 Months
measure: Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure
timeFrame: 12Months
measure: Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure
timeFrame: 24 Months
measure: Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure
timeFrame: 12 Months
measure: Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure
timeFrame: 12 Months
measure: Number of Participants With Cardiac Death at 24 Months Post Procedure
timeFrame: 24 Months
measure: Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure
timeFrame: 24 Months
measure: Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure
timeFrame: 24 Months
measure: Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure
timeFrame: 24 Months
measure: Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure
timeFrame: 24 Months
measure: Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure
timeFrame: 36 Months
measure: Number of Participants With Cardiac Death at 36 Months Post Procedure
timeFrame: 36 Months
measure: Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure
timeFrame: 36 Months
measure: Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure
timeFrame: 36 Months
measure: Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure
timeFrame: 36 Months
measure: Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure
timeFrame: 36 Months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Springfield
country: United States
facility: Saint John's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Saint Louis
country: United States
facility: Barnes Jewish University
state: Missouri
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Medical Center
state: New York
city: Roslyn
country: United States
facility: Saint Francis Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Sanford Medical Center
state: North Dakota
city: Elyria
country: United States
facility: University Hospitals Elyria Medical Center
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health Medical Center
state: South Carolina
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Tyler
country: United States
facility: East Texas Medical Center
state: Texas
Study officials:
affiliation: Scripps Green Hospital
name: Matthew J. Price, MD, FACC, FSCAI
role: PRINCIPAL_INVESTIGATOR
affiliation: Shonan Kamakura General Hospital
name: Shigeru Saito, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.