NCT03647475View on ClinicalTrials.gov

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)

NACompletedINTERVENTIONAL
Enrollment

752

Participants

Timeline

Start Date

October 1, 2018

Primary Completion Date

March 10, 2020

Study Completion Date

April 22, 2021

Conditions
Coronary Artery Disease
Interventions
COMBINATION_PRODUCT

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

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.

Trial Locations (4)

10032

New York- Presbyterian Hospital/Columbia University Medical Center, New York

13057

Saint Joseph's Hospital Health Center, East Syracuse

29621

AnMed Health Medical Center, Anderson

77030

Houston Methodist Hospital, Houston

Sponsors

Lead Sponsor

Medtronic Vascular
All Listed Sponsors
lead

Medtronic Vascular

INDUSTRY