CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 752 enrolled
Drug / intervention
Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPTcombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03647475
NCT03647475N/ACompleted
CompareCT.gov

Onyx ONE Clear: A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)

Medtronic Vascular·interventional·Posted Aug 27, 2018·Updated Nov 1, 2021

In Brief

A clinical study evaluating Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT for Coronary Artery Disease. Completed, enrolled 752 participants across 4 sites.

Detailed Summary

The purpose of this trial is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 27, 2018
Enrollment StartOct 1, 2018
Primary CompletionMar 10, 2020
Study CompletionApr 22, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.8 years ago

Interventions

Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPTcombination

To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.