Trials / Completed
CompletedNCT03584464
RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)
A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 205 (actual)
- Sponsor
- Medtronic Vascular · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System | Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm |
Timeline
- Start date
- 2018-05-14
- Primary completion
- 2020-11-04
- Completion
- 2022-09-28
- First posted
- 2018-07-12
- Last updated
- 2023-11-24
- Results posted
- 2022-01-12
Locations
25 sites across 4 countries: United States, Belgium, France, Slovakia
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03584464. Inclusion in this directory is not an endorsement.