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Sponsors and Collaborators: |
Centre hospitalier de l'Université de Montréal (CHUM) Canadian Institutes of Health Research (CIHR) |
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Information provided by: | Centre hospitalier de l'Université de Montréal (CHUM) |
ClinicalTrials.gov Identifier: | NCT00537134 |
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.
Condition | Intervention |
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Brain Aneurysm |
Device: Embolization, coiling Other: Conservative management |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Endovascular Treatment of Unruptured Intracranial Aneurysms in the Prevention of Aneurysmal Haemorrhages: A Randomized Comparison With Indefinite Deferral of Treatment in 2002 Patients Followed for 10 Years |
Estimated Enrollment: | 2002 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | September 2021 |
Estimated Primary Completion Date: | September 2020 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Conservative management (watchful observation)
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Other: Conservative management
watchful observation until indication for treatment arises
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2: Active Comparator
Endovascular treatment
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Device: Embolization, coiling
Endovascular embolization with platinum coils
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This study is designed as a pragmatic trial. All candidates for endovascular treatment of one or more unruptured intracranial aneurysms will be offered to participate. Unruptured aneurysms may be recently discovered or prevalent. If they accept, subjects will be randomized to one of the two arms of the trial: Conservative management (Observation) or Endovascular treatment.
Both groups will be advised to obtain medical treatment for hypertension if necessary and will receive counselling for behavioural risk factor modelling (smoking or excessive drinking) when indicated. A non-invasive (MRA or CTA) or catheter angiogram and a baseline CT-scan or MRI of the brain are required to enter the study. These studies should demonstrate the unequivocal presence of a saccular aneurysm >=3 mm treatable by endovascular methods. A catheter angiogram is required if there is doubt. Imaging studies will be reviewed centrally. Both treatments will be standardized. Patients will be followed similarly for a minimum of 10 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Guylaine Gevry, BSc | 514-890-8000 ext 27235 | guylaine.gevry@crchum.qc.ca |
Contact: Ruby Klink, PhD | 514-890-8000 ext 25245 | ruby.klink@crchum.qc.ca |
United States, Arizona | |
St Joseph's Hospital & Medical Center | Recruiting |
Phoenix, Arizona, United States | |
Contact: Joanie Cacciola joanie.cacciola@chw.edu | |
Principal Investigator: Cameron McDougall, Dr | |
United States, Massachusetts | |
Boston Medical Center | Recruiting |
Boston, Massachusetts, United States | |
Contact: Andrew Morrisson Andrew.Morrison@bmc.org | |
Principal Investigator: Thanh Nguyen, Dr | |
United States, New York | |
St Luke's-Roosevelt Hospital Center | Recruiting |
New York, New York, United States | |
Contact: Peter Rappa, PRappa@chpnet.org | |
Principal Investigator: Alejandro Berenstein, Dr | |
SUNY Downstate Medical Center | Recruiting |
Brooklyn, New York, United States | |
Contact: Sergey Zhabin Sergey.Zhabin@downstate.edu | |
Principal Investigator: Sundeep Mangla, Dr | |
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States | |
Contact: Adrian Parker parkerad@musc.edu | |
Principal Investigator: Aquilla Turk, Dr | |
United States, Texas | |
The Methodist Hospital | Recruiting |
Houston, Texas, United States | |
Contact: Marilyn Bautista mhbautista@tmhs.org | |
Principal Investigator: Richard Klucznick, Dr | |
Canada, Quebec | |
CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office) | Recruiting |
Montreal, Quebec, Canada, H2L 4M1 | |
Contact: Guylaine Gevry, BSc 514-890-8000 ext 27235 guylaine.gevry@crchum.qc.ca | |
Principal Investigator: Jean Raymond, MD | |
France | |
TEAM France Coordination Unit - CHU Reims CRICAM | Recruiting |
Reims, France | |
Contact: Béatrice Baury 33 3 26 78 92 66 bbaury@chu-reims.fr | |
Principal Investigator: Laurent Pierot, MD | |
Principal Investigator: Christophe Cognard, MD | |
United Kingdom | |
TEAM European Coordination Centre NVRU- Radcliffe Infirmary | Recruiting |
Oxford, United Kingdom | |
Contact: Julia Yarnold 44 1865 617166 julia.yarnold@nds.ox.ac.uk | |
Principal Investigator: Andrew J. Molyneux, MD |
Principal Investigator: | Jean Raymond, MD | Centre hospitalier de l'Université de Montréal - Hôpital Notre-Dame |
Principal Investigator: | Andrew J. Molyneux, MD | NRU, Radcliffe Infirmary Oxford University UK |
Principal Investigator: | Allan J Fox, MD | Sunnybrook Health Sciences Centre and University of Toronto |
Principal Investigator: | Claiborne S. Johnston, MD, PhD | University of California, San Francisco, USA |
Principal Investigator: | Jean-Paul Collet, MD, PhD | University of British Columbia, Vancouver, Canada |
Principal Investigator: | Isabelle Rouleau, PhD | CHUM Hôpital Notre-Dame, Montreal, Canada |
Responsible Party: | Centre Hospitalier de l'Université de Montréal ( Jean Raymond, Dr ) |
Study ID Numbers: | MCT-80799, ISRCTN62758344 |
Study First Received: | September 26, 2007 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00537134 History of Changes |
Health Authority: | Canada: Canadian Institutes of Health Research |
Aneurysm Brain Unruptured |
observation treatment Endovascular |
Intracranial Aneurysm Aneurysm Vascular Diseases Central Nervous System Diseases |
Brain Diseases Hemorrhage Cerebrovascular Disorders Intracranial Arterial Diseases |
Intracranial Aneurysm Aneurysm Nervous System Diseases Vascular Diseases Central Nervous System Diseases |
Cardiovascular Diseases Brain Diseases Cerebrovascular Disorders Intracranial Arterial Diseases |