Condition category
Circulatory System
Date applied
11/09/2006
Date assigned
12/09/2006
Last edited
15/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A brain (intracranial) aneurysm is a bulging, weak area in the wall of a blood vessel supplying blood to the brain. Most aneurysms only cause symptoms if they burst (rupture), which leads to bleeding (haemorrhage) and brain damage. Surgery is recommended if there's a high risk of rupture. Endovascular coiling involves inserting a thin tube into a blood vessel in the leg or groin, which is guided through the blood vessels and into the aneurysm, where tiny coils are passed through the tube into the aneurysm, sealing it off and preventing it from rupturing. The aim of this study is to assess the safety and effectiveness of endovascular treatment at preventing aneurysmal haemorrhage.

Who can participate?
Patients aged 18 or over with an unruptured aneurysm

What does the study involve?
Participants are randomly allocated to one of two groups. One group is treated with endovascular coiling and the other group receives conservative management (watchful observation). Participants are followed up after 1, 5 and 10 years.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Centre Hosp. de l'Université de Montréal (CHUM) (Canada)

When is the study starting and how long is it expected to run for?
August 2006 to September 2023

Who is funding the study?
1. Canadian Institutes of Health Research (CIHR) (Canada)
2. NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Dr Jean Raymond
dr_jean_raymond@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jean Raymond

ORCID ID

Contact details

Centre de Recherche du CHUM - Notre-Dame
Lab. Neuroradiologie Interventionnelle
Pavillon Mailloux
suite M-8203
1560 Sherbrooke Est
Montréal
Quebec
H2L 4M1
Canada
+1 (0)514 890 8000 ext. 27235
dr_jean_raymond@hotmail.com

Type

Public

Additional contact

Dr Guylaine Gevry

ORCID ID

Contact details

Interventional Neuroradiology Research Laboratory
Research Coordinator
CHUM Research Centre
1560 Sherbrooke est
Pavillion Mailloux
suite M-8203
Montreal
H2L 4M1
Canada
+1 (0)514 890 8000 ext. 27235
guylaine.gevry@crchum.qc.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00537134

Protocol/serial number

HTA 06/404/50; MCT-80799

Study information

Scientific title

Safety and efficacy of endovascular treatment of unruptured intracranial aneurysms in the prevention of aneurysmal haemorrage: a randomised comparison with indefinite deferral of treatment

Acronym

TEAM

Study hypothesis

The ten year combined mortality and morbidity (M/M) related to unruptured aneurysms observed in the conservative group will decrease from 8% to 4% (M/M of treatment and haemorrhagic events despite treatment as expressed by a modified Rankin scale more than or equal to three) with endovascular treatment.

Ethics approval

1. Comité d'éthique de la recherche Équipe Hôpital Notre-Dame du CHUM, 15/06/2006
2. Ethics approvals for centers in other countries are pending

Study design

Multicentre multicountry randomised two-arm parallel trial with study investigator and outcomes assessor blinded

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Intracranial aneurysm

Intervention

Intervention group: Endovascular coiling of aneurysm, upon diagnosis
Control group: Conservative management/observation, upon diagnosis

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Disease or treatment-related morbidity and mortality, measured at one year, five and ten years after treatment or observation.

Secondary outcome measures

1. To better define the natural history of unruptured aneurysms eligible for endovascular treatment, measured at five and ten years
2. Define the rate of haemorrhagic events despite endovascular treatment at one year, five and ten years
3. Determine the M/M related to endovascular treatment of unruptured aneurysms at one year, five and ten years
4. Compare overall M/M of the two groups at ten years
5. Compare the quality of life and anxiety levels of surviving patients of the two groups at five and ten years
6. Determine the rate of occlusion of aneurysms treated by coiling in an effort to estimate longer-term efficacy at five and ten years
7. Determine the rate of aneurysmal growth in the conservative group in surviving patients at five and ten years
8. Verify cognitive functions using the Montreal Cognitive Assessment (MoCA) in all patients at baseline, one year, five and ten years; as well as by detailed neuropsychological testing at baseline and six months after treatment in a consecutive sample of 100 patients of both groups

Overall trial start date

01/08/2006

Overall trial end date

30/09/2023

Reason abandoned

Eligibility

Participant inclusion criteria

1. At least one documented subarachnoid aneurysm between 3 and 25 mm, never ruptured
2. Patient aged 18 or older, either sex
3. Life expectancy more than ten years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

Participant exclusion criteria

1. Patients with intracranial haemorrhage
2. Lesion characteristics unsuitable for endovascular treatment
3. Patients with single cavernous aneurysms
4. Aneurysms less than 3 mm or giant aneurysms (more than or equal to 25 mm)
5. Patients with a poor outcome (Rankin scale more than or equal to three) after the rupture, surgical or endovascular treatment of another aneurysm
6. Patients with incompletely treated aneurysms that have previously ruptured
7. Patients with associated arteriovenous malformations
8. 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)
9. Patients with previous intracranial haemorrhage from unknown aetiology
10. Patients with multiple unruptured aneurysms in whom surgical clipping of one or many aneurysms is planned in addition to endovascular management
11. Patients with absolute contraindications to anaesthesia, endovascular treatment, or administration of contrast material, including low-osmolarity agents or gadolinium
12. Pregnant patients

Recruitment start date

01/08/2006

Recruitment end date

30/09/2023

Locations

Countries of recruitment

Australia, Canada, Chile, China, Czech Republic, France, Germany, Greece, Italy, Norway, Russian Federation, Spain, Switzerland, Turkey, United Kingdom, United States of America

Trial participating centre

Centre de Recherche du CHUM - Notre-Dame
Quebec
H2L 4M1
Canada

Sponsor information

Organisation

Centre Hosp. de l'Université de Montréal (CHUM) (Canada)

Sponsor details

Campus Hôtel-Dieu
3840 rue Saint-Urbain
Montréal
Quebec
H2W 1T8
Canada
+1 (0)514 890 8000
mario.deslongchamps.chum@ssss.gouv.qc.ca

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-80799)

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Funder name

Health Technology Assessment Programme: UK trial sites will be funded by the HTA programme from 01/06/2008 for five years

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17316800
2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22518212
2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18631395

Publication citations

  1. Protocol

    Raymond J, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I, , 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, 9, 43, doi: 10.1186/1745-6215-9-43.

  2. Protocol

    Raymond J, Meder JF, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I, , Trial on endovascular treatment of unruptured aneurysms (TEAM): study monitoring and rationale for trial interruption or continuation., J Neuroradiol, 2007, 34, 1, 33-41, doi: 10.1016/j.neurad.2007.01.011.

  3. Protocol

    Raymond J, Roy D, Weill A, Guilbert F, Nguyen T, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; Trial on Endovascular Aneurysm Management (TEAM) collaborative group, Unruptured intracranial aneurysms and the Trial on Endovascular Aneurysm Management (TEAM): The principles behind the protocol, J Vasc Interv Neurol, 2008, 1, 1, 22-26.

Additional files

Editorial Notes

15/03/2016: Plain English summary added.