Trial on Endovascular Aneurysm Management

Brain Aneurysm Clinical Trial

— TEAM  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00537134
• Other study ID #: MCT-80799
• Secondary ID: ISRCTN62758344
• Status: Terminated
• Phase: N/A
• Start date: April 2006
• Est. completion date: July 2009

Study information

• Verified date: December 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: July 2009
• Est. primary completion date: June 28, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Brain Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Embolization, coiling
Endovascular embolization with platinum coils

Locations

Country	Name	City	State
Canada	CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office)	Montreal	Quebec
France	TEAM France Coordination Unit - CHU Reims CRICAM	Reims
United Kingdom	TEAM European Coordination Centre NVRU- Radcliffe Infirmary	Oxford
United States	Boston Medical Center	Boston	Massachusetts
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	The Methodist Hospital	Houston	Texas
United States	St Luke's-Roosevelt Hospital Center	New York	New York
United States	St Joseph's Hospital & Medical Center	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Canada,  France,  United Kingdom, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Disease or Treatment-related Morbidity and Mortality.	Morbidity or mortality is evaluated using the modified Rankin Scale (mRS) which goes from 0 to 6, with 0 for no symptoms at all, and 6 for Mortality. The scores were attributed using a structured interview process.; a "Good" Primary Outcome was categorized from mRS scores of 0, 1, or 2. a "Bad" Primary Outcome was categorized from mRS scores of 3, 4, 5 or 6.	1 year after treatment or observation
Secondary	Rate of Hemorrhage in Conservative Group	To better define the natural history of unruptured aneurysms eligible for endovascular treatment.	At 5 and 10 years
Secondary	Number of Participants With Hemorrhage in Endovascular Group	Number of participants experiencing a hemorrhagic event despite successful treatment.; This outcome measure gives an estimate of risk of rupture despite treatment	At 1 year
Secondary	Number of Participants in Each Score of the Modified Rankin Scale in Endovascular Group	The modified Rankin Scale (mRS) goes from 0 to 6, with 0 for no symptoms at all, and 6 for Mortality. The scores were attributed using a structured interview process.; The number of participants having in each score is given.	At 1 year
Secondary	Modified Rankin Score	To compare overall Morbidity/Mortality of the 2 groups	At 10 years
Secondary	Measures on 36-Item Short-Form Health Survey (SF-36)	To compare the quality of life and anxiety levels of surviving patients of the 2 groups according to the SF-36 questionnaire minimum is 0 (maximum disability) maximum is 100 (No disability)	At 5 and 10 years
Secondary	Occlusion State in the Endovascular Group	To determine the rate of occlusion of aneurysms treated by coiling in an effort to estimate longer-term efficacy.	At 5 and 10 years
Secondary	Occlusion State of the Aneurysm in the Conservative Group	To determine the rate of aneurysmal growth in the conservative group in surviving patients.	At 5 and 10 years
Secondary	Number of Participants With a "Bad" Cognitive Function Evaluated According to the Montreal Cognitive Assessment Scale (MoCA)	To verify cognitive functions using the MoCA in all patients before and 6 months after treatment in a consecutive sample of 100 patients of both groups.; Minimum value on the MoCA is 0 (maximum cognitive decline) Maximum value on the MoCA is 30 (no cognitive decline) A score higher than 26 was categorized as "good" cognitive condition A score of 26 or lower was categorized as "bad" cognitive conditionn	Baseline, 1 year, 5 and 10 years