N/A
N=205
RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT03584464 ↗Enrolled (actual)
205
Serious AEs
23.4%
Results posted
Jan 2022
Primary outcome: Primary: Number of Participants With Target Vessel Failure (TVF) — 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Vascular
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Target Vessel Failure (TVF) |
14 | — |
| SECONDARY Number of Participants With Cardiac Death |
3 | — |
| SECONDARY Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI) |
6 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
7 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TVR) |
8 | — |
| SECONDARY Number of Participants With Cardiac Death and TVMI |
9 | — |
| SECONDARY Number of Participants With Major Adverse Cardiac Event (MACE) |
17 | — |
| SECONDARY Number of Participants With Target Lesion Failure (TLF) |
13 | — |
| SECONDARY Number of Participants With Stent Thrombosis (ARC) Definite/Probable |
— | — |
Summary
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.
To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.
Eligibility Criteria
Key Inclusion Criteria
- Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation and ST-elevation myocardial infarction
- Subject is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use, and the Declaration of Helsinki
- Subject requires treatment of a single de novo bifurcated lesion amenable to treatment with Resolute Onyx using the provisional stenting technique
Exclusion Criteria
- Unprotected left main disease
- Subjects with planned PCI of three vessel disease
- Planned two stent technique (main branch and side branch) of a bifurcation
- Subjects with more than one bifurcation lesion
Data sourced from ClinicalTrials.gov (NCT03584464). 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.