Trial on Endovascular Aneurysm Management - Full Text View

Sponsor:	Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator:	Canadian Institutes of Health Research (CIHR)
Information provided by:	Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:	NCT00537134

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:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy 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

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Brain Aneurysm

U.S. FDA Resources

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
1: No Intervention Conservative management (watchful observation)	Other: Conservative management watchful observation until indication for treatment arises
2: Active Comparator Endovascular treatment	Device: Embolization, coiling Endovascular embolization with platinum 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
St Luke's-Roosevelt Hospital Center
New York, New York, United States
SUNY Downstate Medical Center
Brooklyn, 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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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. Review.

Raymond J, Meder JF, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; The 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. Review. No abstract available.

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.

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. Epub 2003 May 29.

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.

Raymond J, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; the 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(1):43.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Raymond J. Incidental intracranial aneurysms: rationale for treatment. Curr Opin Neurol. 2009 Feb;22(1):96-102.

Responsible Party:	Centre Hospitalier de l'Université de Montréal ( Jean Raymond, Dr )
Study ID Numbers:	MCT-80799, ISRCTN62758344
Study First Received:	September 26, 2007
Last Updated:	July 20, 2009
ClinicalTrials.gov Identifier:	NCT00537134 History of Changes
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:

Intracranial Aneurysm
Aneurysm
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases

Cardiovascular Diseases
Brain Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases

ClinicalTrials.gov processed this record on February 08, 2010