N/A
Completed N=101
Medtronic Resolute Onyx 2.0 mm Clinical Study
Source: ClinicalTrials.gov NCT02412501 ↗Enrolled (actual)
101
Serious AEs
62.4%
Results posted
Apr 2018
Primary outcomePrimary: Number of Participants With Target Lesion Failure at 12 Months Post-Procedure — 5 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Target Lesion Failure at 12 Months Post-Procedure |
5 | — |
| SECONDARY Number of Participants With Cardiac Death at 12 Months Post Procedure |
— | — |
| SECONDARY Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure |
3 | — |
| SECONDARY Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure |
5 | — |
| SECONDARY Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure |
13 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure |
5 | — |
| SECONDARY Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure |
— | — |
| SECONDARY Number of Participants With Cardiac Death at 24 Months Post Procedure |
2 | — |
| SECONDARY Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure |
4 | — |
| SECONDARY Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure |
14 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure |
14 | — |
| SECONDARY Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure |
— | — |
| SECONDARY Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure |
14 | — |
| SECONDARY Number of Participants With Cardiac Death at 36 Months Post Procedure |
2 | — |
| SECONDARY Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure |
4 | — |
| SECONDARY Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure |
15 | — |
| SECONDARY Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure |
15 | — |
| SECONDARY Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02412501). 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. Informational only — not medical advice.