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Trial on Endovascular Aneurysm Management

NCT00537134 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-12-30

Study results available
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Summary

The management of patients with unruptured aneurysms is controversial. Patients with unruptured aneurysms may suffer intracranial hemorrhage, but the incidence of this event is still debated. Endovascular treatment can prevent rupture, but involves immediate risks; furthermore, successful treatment does not eliminate all risks. A randomized trial may be the best way to demonstrate the potential benefits of endovascular over conservative management of unruptured aneurysms.

Conditions

  • Brain Aneurysm

Interventions

DEVICE

Embolization, coiling

Endovascular embolization with platinum coils

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Jean Raymond, MD · Centre hospitalier de l'Université de Montréal - Hôpital Notre-Dame

  • Andrew J. Molyneux, MD · NRU, Radcliffe Infirmary Oxford University UK

  • Allan J Fox, MD · Sunnybrook Health Sciences Centre and University of Toronto

  • Claiborne S. Johnston, MD, PhD · University of California, San Francisco, USA

  • Jean-Paul Collet, MD, PhD · University of British Columbia, Vancouver, Canada

  • Isabelle Rouleau, PhD · CHUM Hôpital Notre-Dame, Montreal, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2009-06-28
Completion
2009-07-31

Countries

  • United States
  • Canada
  • France
  • 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 NCT00537134 on ClinicalTrials.gov