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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN62758344 | Registry Identifier | primary clinical trial registry recognised by WHO and ICMJE |
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The CIHR Financial support was withdrawn because of insufficient recruitment.
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative | No Intervention | Conservative management (watchful observation) | |
| Endovascular | Active Comparator | Endovascular treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embolization, coiling | Device | Endovascular embolization with platinum coils |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Raymond, MD | Centre hospitalier de l'Université de Montréal - 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Joseph's Hospital & Medical Center | Phoenix | Arizona | 85013 | United States | ||
| Boston Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17316800 | Background | 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. | |
| 17041525 |
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there are no pre-assignment procedures before assignment to groups
Participants are recruited when seen in clinic either for neurological symptoms or when aneurysm is an incidental finding
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| ID | Title | Description |
|---|---|---|
| FG000 | Endovascular | Endovascular treatment by coil embolization Embolization, coiling: Endovascular embolization with platinum coils |
| FG001 | Conservative | Conservative management (watchful observation) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conservative | Conservative management (watchful observation) Inclusion criteria:
Exclusion crieria:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 1 year after treatment or observation |
|
The number of patients in each period of time over which Adverse event data was collected is variable, because the study was terminated while patients were at variable points through their expected follow-up period. For example, only 52/80 participants were evaluated at 1 month before the study was terminated; at each subsequent time point, fewer participants were evaluated. - 3 years: 2 patients - 2 years: 11 patients - 1 year: 25 patients - 6 months: 41 patients - 1 month: 52 patients
The definition of adverse event does not differ from the ClinicalTrials.gov definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conservative | Conservative management (watchful observation) | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage | Vascular disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | Non-systematic Assessment |
No conclusions can be drawn from the reported results because the study, projected to follow patients for 10 years was terminated by the funding agency after 3 years
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruby Klink | Centre Hospitalier de l'Université de Montréal (CHUM) | (514) 890-8000 | 27235 | ruby.klink.chum@ssss.gouv.qc.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2007 | Nov 28, 2022 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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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 |
| Boston |
| Massachusetts |
| 02118 |
| United States |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| St Luke's-Roosevelt Hospital Center | New York | New York | 10029-6504 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office) | Montreal | Quebec | H2L 4M1 | Canada |
| TEAM France Coordination Unit - CHU Reims CRICAM | Reims | France |
| TEAM European Coordination Centre NVRU- Radcliffe Infirmary | Oxford | United Kingdom |
| 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. |
| 16484380 | Background | 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. |
| 12775880 | Background | 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. |
| 20587222 | Background | 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. |
| 18631395 | Background | 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. |
| 21330400 | Derived | 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. |
| 19165956 | Derived | Raymond J. Incidental intracranial aneurysms: rationale for treatment. Curr Opin Neurol. 2009 Feb;22(1):96-102. doi: 10.1097/wco.0b013e32831fee91. |
| BG001 | Endovascular | Endovascular treatment Embolization, coiling: Endovascular embolization with platinum coils Same population as Conservative management |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Endovascular | Endovascular treatment Embolization, coiling: Endovascular embolization with platinum coils Same population as Conservative management |
|
|
| Secondary | Rate of Hemorrhage in Conservative Group | To better define the natural history of unruptured aneurysms eligible for endovascular treatment. | No patients available for outcome measure at 5 years because study was terminated | Posted | 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 | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | At 1 year |
|
|
|
| Secondary | Modified Rankin Score | To compare overall Morbidity/Mortality of the 2 groups | No patients available for outcome measure at 10 years because study was terminated | Posted | 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) | No patients available for outcome measure at 5 and 10 years because study was terminated | Posted | 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. | No patients available for outcome measure at 5 years because study was terminated | Posted | 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. | No patients available for outcome measure at 5 years because study was terminated | Posted | 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 | Patients with MoCa scores at Baseline and 1 year | Posted | Count of Participants | Participants | Baseline, 1 year, 5 and 10 years |
|
|
|
| 38 |
| 0 |
| 38 |
| 2 |
| 38 |
| EG001 | Endovascular | Endovascular treatment Embolization, coiling: Endovascular embolization with platinum coils | 0 | 42 | 1 | 42 | 3 | 42 |
| Migraine | General disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| arm hematoma | Surgical and medical procedures | Non-systematic Assessment | hematoma resulting from arm arterial line complication |
|
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| mRS is 2 |
|
| 1 year |
|