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The OMEGA Clinical Trial

NCT01419171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2014-09-25

Study results available
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Summary

The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery lesion.

Conditions

Interventions

DEVICE

OMEGA™ Monorail Coronary Stent System

All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Peter Maurer, MPH · Boston Scientific Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-10-31
Completion
2014-01-31

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Latvia
  • Netherlands
  • Spain

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 NCT01419171 on ClinicalTrials.gov