Clinical trial NCT00537134: Trial on Endovascular Aneurysm Management
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Brain Aneurysm
Keywords: Aneurysm
Brain
Unruptured
observation
treatment
Endovascular
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2007-09-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* At least one documented subarachnoid aneurysm, never ruptured
* Patient aged 18 or older
* Life expectancy more than 10 years

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Disease or Treatment-related Morbidity and Mortality.
timeFrame: 1 year after treatment or observation
Secondary outcomes:
measure: Rate of Hemorrhage in Conservative Group
timeFrame: At 5 and 10 years
measure: Number of Participants With Hemorrhage in Endovascular Group
timeFrame: At 1 year
measure: Number of Participants in Each Score of the Modified Rankin Scale in Endovascular Group
timeFrame: At 1 year
measure: Modified Rankin Score
timeFrame: At 10 years
measure: Measures on 36-Item Short-Form Health Survey (SF-36)
timeFrame: At 5 and 10 years
measure: Occlusion State in the Endovascular Group
timeFrame: At 5 and 10 years
measure: Occlusion State of the Aneurysm in the Conservative Group
timeFrame: At 5 and 10 years
measure: Number of Participants With a "Bad" Cognitive Function Evaluated According to the Montreal Cognitive Assessment Scale (MoCA)
timeFrame: Baseline, 1 year, 5 and 10 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St Joseph's Hospital & Medical Center
state: Arizona
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: New York
country: United States
facility: St Luke's-Roosevelt Hospital Center
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Montreal
country: Canada
facility: CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office)
state: Quebec
city: Reims
country: France
facility: TEAM France Coordination Unit - CHU Reims CRICAM
city: Oxford
country: United Kingdom
facility: TEAM European Coordination Centre NVRU- Radcliffe Infirmary
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal - Hôpital Notre-Dame
name: Jean Raymond, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NRU, Radcliffe Infirmary Oxford University UK
name: Andrew J. Molyneux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre and University of Toronto
name: Allan J Fox, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco, USA
name: Claiborne S. Johnston, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia, Vancouver, Canada
name: Jean-Paul Collet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHUM Hôpital Notre-Dame, Montreal, Canada
name: Isabelle Rouleau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raymond J, Meder JF, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; Trial on Endovascular Aneurysm Management (TEAM) collaborative group. Trial on endovascular treatment of unruptured aneurysms (TEAM): study monitoring and rationale for trial interruption or continuation. J Neuroradiol. 2007 Mar;34(1):33-41. doi: 10.1016/j.neurad.2007.01.011.
citation: Raymond J, Meder JF, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; Trial On Endovascular Aneurysm Management Team Collaborative Group. Unruptured intracranial aneurysms: the unreliability of clinical judgment, the necessity for evidence, and reasons to participate in a randomized trial. J Neuroradiol. 2006 Oct;33(4):211-9. doi: 10.1016/s0150-9861(06)77266-2. No abstract available.
citation: Raymond J, Guilbert F, Weill A, Roy D. Unruptured intracranial aneurysms: a call for a randomized clinical trial. AJNR Am J Neuroradiol. 2006 Feb;27(2):242-3. No abstract available.
citation: Raymond J, Guilbert F, Weill A, Georganos SA, Juravsky L, Lambert A, Lamoureux J, Chagnon M, Roy D. Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke. 2003 Jun;34(6):1398-403. doi: 10.1161/01.STR.0000073841.88563.E9. Epub 2003 May 29.
citation: Raymond J, Chagnon M, Collet JP, Guilbert F, Weill A, Roy D. A randomized trial on the safety and efficacy of endovascular treatment of unruptured intracranial aneurysms is feasible. Interv Neuroradiol. 2004 Jun 29;10(2):103-12. doi: 10.1177/159101990401000202. Epub 2004 Oct 22.
citation: Raymond J, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; TEAM Collaborative Group. The TEAM trial: safety and efficacy of endovascular treatment of unruptured intracranial aneurysms in the prevention of aneurysmal hemorrhages: a randomized comparison with indefinite deferral of treatment in 2002 patients followed for 10 years. Trials. 2008 Jul 16;9:43. doi: 10.1186/1745-6215-9-43.
citation: Naggara O, Raymond J, Guilbert F, Roy D, Weill A, Altman DG. Analysis by categorizing or dichotomizing continuous variables is inadvisable: an example from the natural history of unruptured aneurysms. AJNR Am J Neuroradiol. 2011 Mar;32(3):437-40. doi: 10.3174/ajnr.A2425. Epub 2011 Feb 17.
citation: Raymond J. Incidental intracranial aneurysms: rationale for treatment. Curr Opin Neurol. 2009 Feb;22(1):96-102. doi: 10.1097/wco.0b013e32831fee91.