Trial on Endovascular Aneurysm Management
Stopped early · Not applicable
Conditions studied: Brain Aneurysm
In brief
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.
Key facts
- Study ID
- NCT00537134
- Run by
- Centre hospitalier de l'Université de Montréal (CHUM)
- People needed
- 80
- Starts
- 2006-04-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2022-12-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- At least one documented subarachnoid aneurysm, never ruptured
- Patient aged 18 or older
- Life expectancy more than 10 years
You may not qualify if…
- Patients with recent (less than 3 months) intracranial haemorrhage
- Lesion characteristics unsuitable for endovascular treatment
- Patients with a single extradural aneurysm
- Aneurysms < 3 mm or giant aneurysms (≥ 25 mm)
- Patients with a poor outcome (Rankin scale ≥ 3) after the rupture, surgical or endovascular treatment of another aneurysm
- Patients with incompletely treated aneurysms that have previously ruptured
- Patients with associated arteriovenous malformations
- Patients with new severe progressive symptoms in relationship with the aneurysm (sudden onset, severe persisting headaches suggestive of impending rupture, third-nerve palsy, mass-effect)
- Patients with previous intracranial haemorrhage from unknown etiology
- Patients with 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
- Patients unable to give informed consent
Where it is running
- St Joseph's Hospital & Medical Center — Phoenix, Arizona, United States
- Boston Medical Center — Boston, Massachusetts, United States
- SUNY Downstate Medical Center — Brooklyn, New York, United States
- St Luke's-Roosevelt Hospital Center — New York, New York, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- The Methodist Hospital — Houston, Texas, United States
- CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office) — Montreal, Quebec, Canada
- TEAM France Coordination Unit - CHU Reims CRICAM — Reims, France
- TEAM European Coordination Centre NVRU- Radcliffe Infirmary — Oxford, United Kingdom
Full record on ClinicalTrials.gov
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