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A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients

NCT03344653 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2020-12-02

No results posted yet for this study

Summary

The purpose of this study 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

DEVICE

Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System

Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT

DEVICE

Biosensors BioFreedom BA9 Drug Coated Coronary Stent

Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT

Sponsors & Collaborators

  • Medtronic Vascular

    lead INDUSTRY

Principal Investigators

  • Stephan Windecker, MD · Bern University Hospital, Bern, Switzerland

  • Azeem Latib, MD · San Raffaele Scientific Institute, Milan, Italy

  • Elvin Kedhi, MD · Isala Zwolle, Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-02
Primary Completion
2018-09-27
Completion
2020-10-09

Countries

  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • France
  • Hong Kong
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Malaysia
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Thailand
  • United Kingdom

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 NCT03344653 on ClinicalTrials.gov