N/A
N=75
Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02419521 ↗Enrolled (actual)
75
Serious AEs
36.0%
Results posted
Jul 2017
Primary outcome: Primary: In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography — 0.24 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resolute Onyx Stent - 2.25 mm - 4.0 mm (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Vascular
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography |
0.24 | — |
| SECONDARY Cardiac Death |
— | — |
| SECONDARY Target Vessel Myocardial Infarction (TVMI) |
2 | — |
| SECONDARY Target Lesion Revascularization (TLR) |
3 | — |
| SECONDARY Major Adverse Cardiac Event (MACE) |
7 | — |
| SECONDARY Target Lesion Failure (TLF) |
5 | — |
| SECONDARY Target Vessel Failure (TVF) |
9 | — |
| SECONDARY Stent Thrombosis (ST) |
1 | — |
| SECONDARY Cardiac Death and TVMI |
2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
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
Data sourced from ClinicalTrials.gov (NCT02419521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.