TEAM
Trial on Endovascular Aneurysm Management
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Status:
Suspended (because of withdrawal of CIHR financial support due to insufficient recruitment)
Purpose:
To demonstrate the potential benefits of endovascular over conservative management of unruptured aneurysms.
Interventions:
Coil Embolization
Detachable coil embolization offers a new approach to treating aneurysms and other blood vessel malformations in the brain. Cerebral angiography, computed tomography (CT) or magnetic resonance (MR) imaging can detect brain aneurysms prior to rupturing.
Interventional neuroradiologists perform detachable coil embolization to alleviate much of the danger presented by aneurysms. The interventional neuroradiologist inserts a tube, called a catheter, into an artery in the leg. This catheter is then maneuvered through the body to the aneurysm's position. Once in position, the radiologist places one or more small coils through the catheter into the aneurysm. The body responds by forming a blood clot around the coil blocking off the aneurysm.
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Location(s):
Canada, United States,
France, UK, Spain, Poland, Germany,
Brazil
Year Started:
2006
Design:
Interventional, Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study.
Inclusion Criteria
At least one documented subarachnoid aneurysm, never ruptured; life expectancy more than 10 years.
Exclusion Criteria
Recent (less than 3 months) intracranial hemorrhage; lesion characteristics unsuitable for endovascular treatment; patients with a single extradural aneurysm; aneurysms <3mm or giant aneurysms (≥25mm); patients with a poor outcome (Rankin scale ≥3) after the rupture, surgical or endovascular treatment of another aneurysm; incompletely treated aneurysms that have previously ruptured; associated arteriovenous malformations; new severe progressive symptoms in relationship with the aneurysm (sudden onset, severe persisting headaches suggestive of impending rupture, third-nerve palsy, mass-effect); previous intracranial haemorrhage from unknown etiology; multiple unruptured aneurysms in whom surgical clipping of one or many aneurysms is planned in addition to endovascular management; patients with absolute contraindications to anaesthesia, endovascular treatment, or administration of contrast material, including low-osmolarity agents or gadolinium; pregnant patients.
Patient Involvement:
Patients 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 counseling for behavioral risk factor modeling (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 >=3mm 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. In addition they will be seen and tested at 1 year, 5 years and 10 years.
Primary Outcome:
Primary outcome is disease or treatment-related morbidity and mortality.
Secondary Outcome:
To better define the natural history of unruptured aneurysms eligible for endovascular treatment; to define the rate of hemorrhagic events despite endovascular treatment; to determine the Morbidity/Mortality (M/M) related to endovascular treatment of unruptured aneurysms; to compare overall M/M of the 2 groups; to compare the quality of life and anxiety levels of surviving patients of the 2 groups;
to determine the rate of occlusion of aneurysms treated by coiling in an effort to estimate longer-term efficacy; to determine the rate of aneurysmal growth in the conservative group in surviving patients; to verify cognitive functions using the MoCA in all patients as well as by detailed neuropsychological testing, before and 6 months after treatment in a consecutive sample of 100 patients of both groups.
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Source of Information:
ClinicalTrials.gov
Ruby Klink
Interventional Neuroradiology Research Laboratory
CHUM Research Centre
Montreal, Quebec
Email:
ruby.klink@crchum.qc.ca
Tel: 1-514-890-8000 extension 25245
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Web Links and Publications:
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This information last updated on: 7/21/2009
Reviewed on: 07/21/2009.
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