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Trial on Endovascular Aneurysm Management (TEAM)

Primary Purpose

Brain Aneurysm

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Embolization, coiling
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Aneurysm focused on measuring Aneurysm, Brain, Unruptured, observation, treatment, Endovascular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Joseph's Hospital & Medical Center
  • Boston Medical Center
  • SUNY Downstate Medical Center
  • St Luke's-Roosevelt Hospital Center
  • Medical University of South Carolina
  • The Methodist Hospital
  • CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office)
  • TEAM France Coordination Unit - CHU Reims CRICAM
  • TEAM European Coordination Centre NVRU- Radcliffe Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Conservative

Endovascular

Arm Description

Conservative management (watchful observation)

Endovascular treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of Hemorrhage in Conservative Group
To better define the natural history of unruptured aneurysms eligible for endovascular treatment.
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
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.
Modified Rankin Score
To compare overall Morbidity/Mortality of the 2 groups
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)
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.
Occlusion State of the Aneurysm in the Conservative Group
To determine the rate of aneurysmal growth in the conservative group in surviving patients.
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

Full Information

First Posted
September 26, 2007
Last Updated
December 6, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00537134
Brief Title
Trial on Endovascular Aneurysm Management
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
The CIHR Financial support was withdrawn because of insufficient recruitment.
Study Start Date
April 2006 (Actual)
Primary Completion Date
June 28, 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Aneurysm
Keywords
Aneurysm, Brain, Unruptured, observation, treatment, Endovascular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative
Arm Type
No Intervention
Arm Description
Conservative management (watchful observation)
Arm Title
Endovascular
Arm Type
Active Comparator
Arm Description
Endovascular treatment
Intervention Type
Device
Intervention Name(s)
Embolization, coiling
Other Intervention Name(s)
Standard and bioactive coils
Intervention Description
Endovascular embolization with platinum coils
Primary Outcome Measure Information:
Title
Number of Participants With Disease or Treatment-related Morbidity and Mortality.
Description
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.
Time Frame
1 year after treatment or observation
Secondary Outcome Measure Information:
Title
Rate of Hemorrhage in Conservative Group
Description
To better define the natural history of unruptured aneurysms eligible for endovascular treatment.
Time Frame
At 5 and 10 years
Title
Number of Participants With Hemorrhage in Endovascular Group
Description
Number of participants experiencing a hemorrhagic event despite successful treatment. This outcome measure gives an estimate of risk of rupture despite treatment
Time Frame
At 1 year
Title
Number of Participants in Each Score of the Modified Rankin Scale in Endovascular Group
Description
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.
Time Frame
At 1 year
Title
Modified Rankin Score
Description
To compare overall Morbidity/Mortality of the 2 groups
Time Frame
At 10 years
Title
Measures on 36-Item Short-Form Health Survey (SF-36)
Description
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)
Time Frame
At 5 and 10 years
Title
Occlusion State in the Endovascular Group
Description
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
Title
Occlusion State of the Aneurysm in the Conservative Group
Description
To determine the rate of aneurysmal growth in the conservative group in surviving patients.
Time Frame
At 5 and 10 years
Title
Number of Participants With a "Bad" Cognitive Function Evaluated According to the Montreal Cognitive Assessment Scale (MoCA)
Description
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
Time Frame
Baseline, 1 year, 5 and 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Raymond, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal - Hôpital Notre-Dame
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew J. Molyneux, MD
Organizational Affiliation
NRU, Radcliffe Infirmary Oxford University UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allan J Fox, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre and University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claiborne S. Johnston, MD, PhD
Organizational Affiliation
University of California, San Francisco, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Paul Collet, MD, PhD
Organizational Affiliation
University of British Columbia, Vancouver, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isabelle Rouleau, PhD
Organizational Affiliation
CHUM Hôpital Notre-Dame, Montreal, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Joseph's Hospital & Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
St Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10029-6504
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
TEAM France Coordination Unit - CHU Reims CRICAM
City
Reims
Country
France
Facility Name
TEAM European Coordination Centre NVRU- Radcliffe Infirmary
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17316800
Citation
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.
Results Reference
background
PubMed Identifier
17041525
Citation
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.
Results Reference
background
PubMed Identifier
16484380
Citation
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.
Results Reference
background
PubMed Identifier
12775880
Citation
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.
Results Reference
background
PubMed Identifier
20587222
Citation
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.
Results Reference
background
PubMed Identifier
18631395
Citation
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.
Results Reference
background
PubMed Identifier
21330400
Citation
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.
Results Reference
derived
PubMed Identifier
19165956
Citation
Raymond J. Incidental intracranial aneurysms: rationale for treatment. Curr Opin Neurol. 2009 Feb;22(1):96-102. doi: 10.1097/wco.0b013e32831fee91.
Results Reference
derived

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