Trial on Endovascular Management of Unruptured Aneurysms
| ISRCTN | ISRCTN62758344 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62758344 |
| ClinicalTrials.gov number | NCT00537134 |
| Secondary identifying numbers | HTA 06/404/50; MCT-80799 |
- Submission date
- 11/09/2006
- Registration date
- 12/09/2006
- Last edited
- 10/02/2021
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Centre de Recherche du CHUM - Notre-Dame
Lab. Neuroradiologie Interventionnelle
Pavillon Mailloux, suite M-8203
1560 Sherbrooke Est
Montréal
Quebec
H2L 4M1
Canada
| Phone | +1 (0)514 890 8000 ext. 27235 |
|---|---|
| dr_jean_raymond@hotmail.com |
Public
Interventional Neuroradiology Research Laboratory
Research Coordinator
CHUM Research Centre
1560 Sherbrooke est
Pavillion Mailloux, suite M-8203
Montreal
H2L 4M1
Canada
| Phone | +1 (0)514 890 8000 ext. 27235 |
|---|---|
| guylaine.gevry@crchum.qc.ca |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | TEAM |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | Intracranial aneurysm |
| Intervention | Intervention group: Endovascular coiling of aneurysm, upon diagnosis Control group: Conservative management/observation, upon diagnosis |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 study start date | 01/08/2006 |
| Completion date | 30/09/2023 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2000 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 30/09/2023 |
Locations
Countries of recruitment
- Australia
- Canada
- Chile
- China
- Czech Republic
- France
- Germany
- Greece
- Italy
- Norway
- Russian Federation
- Spain
- Switzerland
- Türkiye
- United Kingdom
- United States of America
Study participating centre
H2L 4M1
Canada
Sponsor information
University/education
Campus Hôtel-Dieu
3840 rue Saint-Urbain
Montréal
Quebec
H2W 1T8
Canada
| Phone | +1 (0)514 890 8000 |
|---|---|
| mario.deslongchamps.chum@ssss.gouv.qc.ca | |
"ROR" |
https://ror.org/0410a8y51 |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/03/2007 | Yes | No | |
| Protocol article | protocol | 01/01/2008 | Yes | No | |
| Protocol article | protocol | 16/07/2008 | Yes | No |
Editorial Notes
10/02/2021: Internal review.
09/07/2019: The study was stopped due to loss of funding.
15/03/2016: Plain English summary added.
