Trial on Endovascular Aneurysm Management (TEAM)
This study has suspended participant recruitment.
(The CIHR Financial support was withdrawn because of insufficient recruitment)
Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT00537134
First received: September 26, 2007
Last updated: July 9, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Brain Aneurysm |
Device: Embolization, coiling Other: Conservative management |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):
Primary Outcome Measures:
- Primary outcome is disease or treatment-related morbidity and mortality. [ Time Frame: 1 year, 5 year and 10 years after treatment or observation ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To better define the natural history of unruptured aneurysms eligible for endovascular treatment. [ Time Frame: At 5 and 10 years ] [ Designated as safety issue: No ]
- To define the rate of hemorrhagic events despite endovascular treatment. [ Time Frame: At 1, 5 and 10 years ] [ Designated as safety issue: Yes ]
- To determine the Morbidity/Mortality (M/M) related to endovascular treatment of unruptured aneurysms. [ Time Frame: At 1, 5 and 10 years ] [ Designated as safety issue: Yes ]
- To compare overall M/M of the 2 groups [ Time Frame: At 10 years ] [ Designated as safety issue: Yes ]
- To compare the quality of life and anxiety levels of surviving patients of the 2 groups. [ Time Frame: At 5 and 10 years ] [ Designated as safety issue: No ]
- To determine the rate of occlusion of aneurysms treated by coiling in an effort to estimate longer-term efficacy. [ Time Frame: At 5 and 10 years ] [ Designated as safety issue: No ]
- To determine the rate of aneurysmal growth in the conservative group in surviving patients. [ Time Frame: At 5 and 10 years ] [ Designated as safety issue: No ]
- To verify cognitive functions using the MoCA in all patients as well as by detailed neuropsychological testing, before and 6 months after treatment in a consecutive sample of 100 patients of both groups. [ Time Frame: Baseline, 1 year, 5 and 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2002 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | September 2021 |
| Estimated Primary Completion Date: | September 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Conservative management (watchful observation)
|
Other: Conservative management
watchful observation until indication for treatment arises
|
|
Active Comparator: 2
Endovascular treatment
|
Device: Embolization, coiling
Endovascular embolization with platinum coils
Other Name: Standard and bioactive coils
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00537134
Locations
| United States, Arizona | |
| St Joseph's Hospital & Medical Center | |
| Phoenix, Arizona, United States | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States | |
| United States, New York | |
| SUNY Downstate Medical Center | |
| Brooklyn, New York, United States | |
| St Luke's-Roosevelt Hospital Center | |
| New York, New York, United States | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States | |
| United States, Texas | |
| The Methodist Hospital | |
| Houston, Texas, United States | |
| Canada, Quebec | |
| CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office) | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| France | |
| TEAM France Coordination Unit - CHU Reims CRICAM | |
| Reims, France | |
| United Kingdom | |
| TEAM European Coordination Centre NVRU- Radcliffe Infirmary | |
| Oxford, United Kingdom | |
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Canadian Institutes of Health Research (CIHR)
Investigators
| Principal Investigator: | 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 |
More Information
Publications:
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;10(2):103-112.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Centre hospitalier de l'Université de Montréal (CHUM) |
| ClinicalTrials.gov Identifier: | NCT00537134 History of Changes |
| Other Study ID Numbers: | MCT-80799, ISRCTN62758344 |
| Study First Received: | September 26, 2007 |
| Last Updated: | July 9, 2012 |
| Health Authority: | Canada: Canadian Institutes of Health Research |
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
|
Aneurysm Brain Unruptured |
observation treatment Endovascular |
Additional relevant MeSH terms:
|
Aneurysm Intracranial Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013