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RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

NCT03584464 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2023-11-24

Study results available
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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

DEVICE

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm

Sponsors & Collaborators

  • Medtronic Vascular

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-14
Primary Completion
2020-11-04
Completion
2022-09-28
FDA Device
Yes

Countries

  • United States
  • Belgium
  • France
  • Slovakia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03584464 on ClinicalTrials.gov