MedTrace Logo

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)

NCT03647475 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 752

Last updated 2021-11-01

Study results available
· View outcomes & findings →

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.

Conditions

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.

Sponsors & Collaborators

  • Medtronic Vascular

    lead INDUSTRY

Principal Investigators

  • David Kandzari, MD · Piedmont Atlanta Hospital, Atlanta, GA

  • Ajay Kirtane, MD · New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2020-03-10
Completion
2021-04-22
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03647475 on ClinicalTrials.gov