Trial on Endovascular Aneurysm Management (TEAM)

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

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.

Study Overview

• Status: Terminated
• Conditions: Brain Aneurysm
• Intervention / Treatment: Device: Embolization, coiling

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office)
• France
  • Reims, France
    • TEAM France Coordination Unit - CHU Reims CRICAM
• United Kingdom
  • Oxford, United Kingdom
    • TEAM European Coordination Centre NVRU- Radcliffe Infirmary
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St Joseph's Hospital & Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center
    • New York, New York, United States, 10029-6504
      • St Luke's-Roosevelt Hospital Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • The Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conservative; Conservative management (watchful observation)
Active Comparator: Endovascular; Endovascular treatment	Device: Embolization, coiling; Endovascular embolization with platinum coils; Other Names: Standard and bioactive coils

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Hemorrhage in Conservative Group	To better define the natural history of unruptured aneurysms eligible for endovascular treatment.	At 5 and 10 years
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
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
Modified Rankin Score	To compare overall Morbidity/Mortality of the 2 groups	At 10 years
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
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
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
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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Jean Raymond, MD, Centre Hospitalier de L'Universite de Montreal - 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Raymond J. Incidental intracranial aneurysms: rationale for treatment. Curr Opin Neurol. 2009 Feb;22(1):96-102. doi: 10.1097/wco.0b013e32831fee91.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2006
• Primary Completion (Actual): June 28, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: September 26, 2007
• First Submitted That Met QC Criteria: September 27, 2007
• First Posted (Estimate): September 28, 2007

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: treatment; Brain; Aneurysm; observation; Endovascular; Unruptured
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: MCT-80799; ISRCTN62758344 (Registry Identifier: primary clinical trial registry recognised by WHO and ICMJE)