Brain AneurysmTEAMNCT00537134
Trial on Endovascular Aneurysm Management
A study testing Embolization, coiling in people with Brain Aneurysm, run by Centre hospitalier de l'Université de Montréal (CHUM) at 9 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Aneurysm
- What is being tested?
- Embolization, coiling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Apr 2006to Jul 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one documented subarachnoid aneurysm, never ruptured
- Patient aged 18 or older
- Life expectancy more than 10 years
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United States6 sites
Boston Medical Center
Boston, Massachusetts, 02118
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Medical University of South Carolina
Charleston, South Carolina, 29425
The Methodist Hospital
Houston, Texas, 77030
St Luke's-Roosevelt Hospital Center
New York, New York, 10029-6504
St Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
Canada1 site
CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office)
Montreal, Quebec, H2L 4M1
United Kingdom1 site
TEAM European Coordination Centre NVRU- Radcliffe Infirmary
Oxford
About this study
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
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.
Read the 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.
- Conditions
- Brain Aneurysm
- Being tested
- Embolization, coiling
- Keywords
- Aneurysm, Brain, Unruptured, observation, treatment, Endovascular
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embolization, coilingDevice
Also called Standard and bioactive coils
Endovascular embolization with platinum coils
| Study group | Role | What they receive |
|---|---|---|
| Conservative | No intervention | Conservative management (watchful observation) |
| Endovascular | Active comparator | Endovascular treatment Receives: Device: Embolization, coiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after treatment or observation
Secondary outcomes (8)
Rate of Hemorrhage in Conservative Group
To better define the natural history of unruptured aneurysms eligible for endovascular treatment.
Measured: 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
Measured: 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.
Measured: At 1 year
Modified Rankin Score
To compare overall Morbidity/Mortality of the 2 groups
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, 1 year, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startApr 2006
- Primary completion28 Jun 2009
- Study completionJul 2009
Why it stopped: The CIHR Financial support was withdrawn because of insufficient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Brain AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Jean Raymond, MD, Principal investigator, Centre hospitalier de l'Université de Montréal - Hôpital Notre-DameAndrew J. Molyneux, MD, Principal investigator, NRU, Radcliffe Infirmary Oxford University UKAllan J Fox, MD, Principal investigator, Sunnybrook Health Sciences Centre and University of TorontoClaiborne S. Johnston, MD, PhD, Principal investigator, University of California, San Francisco, USAJean-Paul Collet, MD, PhD, Principal investigator, University of British Columbia, Vancouver, CanadaIsabelle Rouleau, PhD, Principal investigator, CHUM Hôpital Notre-Dame, Montreal, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537134
- Sponsor's protocol ID
- MCT-80799
- Other IDs
- ISRCTN62758344
- Acronym
- TEAM
- Status last verified
- Dec 2022
- First submitted
- 26 Sep 2007
- Last updated
- 30 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 17316800Raymond 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.
PubMed 17041525Raymond 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.
PubMed 16484380Raymond 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.
PubMed 12775880Raymond 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.
PubMed 20587222Raymond 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.
PubMed 18631395Naggara 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.
PubMed 21330400Raymond J. Incidental intracranial aneurysms: rationale for treatment. Curr Opin Neurol. 2009 Feb;22(1):96-102. doi: 10.1097/wco.0b013e32831fee91.
PubMed 19165956
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study 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
- ClinicalTrials.gov ID
- NCT00537134
- Acronym / sponsor ID
- TEAM / MCT-80799
- Conditions
- Brain Aneurysm
- Keywords
- Aneurysm, Brain, Unruptured, observation, treatment, Endovascular
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The CIHR Financial support was withdrawn because of insufficient recruitment.
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2006 (actual)
- Primary completion
- 28 Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 28 Sep 2007 (estimated)
- Results
- Posted 30 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative | No intervention | –Conservative management (watchful observation) |
| Endovascular | Active comparator | Device: Embolization, coilingEndovascular treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least one documented subarachnoid aneurysm, never ruptured
- Patient aged 18 or older
- Life expectancy more than 10 years
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embolization, coilingAlso: Standard and bioactive coilsEndovascular embolization with platinum coils | Device | Endovascular |
Primary outcome
Number of Participants With Disease or Treatment-related Morbidity and Mortality.
Time frame: 1 year after treatment or observation
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.
8 secondary outcomes
Rate of Hemorrhage in Conservative Group
Time frame: At 5 and 10 years
Number of Participants With Hemorrhage in Endovascular Group
Time frame: At 1 year
Number of Participants in Each Score of the Modified Rankin Scale in Endovascular Group
Time frame: At 1 year
Modified Rankin Score
Time frame: At 10 years
Measures on 36-Item Short-Form Health Survey (SF-36)
Time frame: At 5 and 10 years
Occlusion State in the Endovascular Group
Time frame: At 5 and 10 years
Occlusion State of the Aneurysm in the Conservative Group
Time frame: At 5 and 10 years
Number of Participants With a "Bad" Cognitive Function Evaluated According to the Montreal Cognitive Assessment Scale (MoCA)
Time frame: Baseline, 1 year, 5 and 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17316800Raymond 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.
- Background: PubMed 17041525Raymond 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.
- Background: PubMed 16484380Raymond 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.
- Background: PubMed 12775880Raymond 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.
- Background: PubMed 20587222Raymond 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.
- Background: PubMed 18631395Raymond 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.
- Derived from this study: PubMed 21330400Naggara 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.
- Derived from this study: PubMed 19165956Raymond J. Incidental intracranial aneurysms: rationale for treatment. Curr Opin Neurol. 2009 Feb;22(1):96-102. doi: 10.1097/wco.0b013e32831fee91.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Raymond, MD principal investigator
Centre hospitalier de l'Université de Montréal - Hôpital Notre-Dame
Andrew J. Molyneux, MD principal investigator
NRU, Radcliffe Infirmary Oxford University UK
Allan J Fox, MD principal investigator
Sunnybrook Health Sciences Centre and University of Toronto
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embolization, coiling in people with Brain Aneurysm, run by Centre hospitalier de l'Université de Montréal (CHUM) at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Disease or Treatment-related Morbidity and Mortality. (time frame: 1 year after treatment or observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00537134, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2022.