Medtronic Resolute Onyx 2.0 mm Clinical Study
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Resolute Onyx Stent - 2.0 mm
- Registration Number
- NCT02412501
- Lead Sponsor
- Medtronic Vascular
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Device Resolute Onyx Stent - 2.0 mm Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System 2.0 mm Stent
- Primary Outcome Measures
Name Time Method Number of Participants With Target Lesion Failure at 12 Months Post-Procedure 12 Months 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure 36 Months 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 TVMI defined as Q Wave or non-Q Wave MI
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 Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure 12 Months Number of Participants With Cardiac Death at 24 Months Post Procedure 24 Months Number of Participants With Cardiac Death at 36 Months Post Procedure 36 Months Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure 24 Months TVMI defined as Q Wave or non-Q Wave MI
Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure 24 Months Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure 24 Months Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure 24 Months Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure 36 Months Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure 36 Months TVMI defined as Q Wave or non-Q Wave MI
Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure 36 Months Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure 36 Months
Trial Locations
- Locations (17)
NYU Langone Medical Center
🇺🇸New York, New York, United States
Barnes Jewish University
🇺🇸Saint Louis, Missouri, United States
Saint John's Hospital
🇺🇸Springfield, Illinois, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
The Mount Sinai Medical Center
🇺🇸New York, New York, United States
University Hospitals Elyria Medical Center
🇺🇸Elyria, Ohio, United States
Saint Francis Hospital
🇺🇸Roslyn, New York, United States
Sanford Medical Center
🇺🇸Fargo, North Dakota, United States
East Texas Medical Center
🇺🇸Tyler, Texas, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
St. Vincent Heart Center of Indiana
🇺🇸Indianapolis, Indiana, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
AnMed Health Medical Center
🇺🇸Anderson, South Carolina, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States