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Coronary Sinus Reducer for Treatment of Refractory Angina - COSIRA

NCT01205893 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2013-11-25

No results posted yet for this study

Summary

The purpose of this study is to determine if the Reducer is safe and effective in treating the symptoms of refractory angina in patients that suffer from refractory angina who demonstrate reversible ischemia.

Conditions

  • Refractory Angina

Interventions

DEVICE

Neovasc Reducer

Implantation of the Reducer

DEVICE

Control

Control - No device implanted

Sponsors & Collaborators

  • Shockwave Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Stefan Verheye, MD · ZNA Middelheim Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-10-31
Completion
2013-11-30

Countries

  • Belgium
  • Canada
  • Denmark
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

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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 NCT01205893 on ClinicalTrials.gov