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Trial on Endovascular Aneurysm Management

NCT ID: NCT00537134

Last Updated: 2022-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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

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Brain Aneurysm

Keywords

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Aneurysm Brain Unruptured observation treatment Endovascular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conservative

Conservative management (watchful observation)

Group Type NO_INTERVENTION

No interventions assigned to this group

Endovascular

Endovascular treatment

Group Type ACTIVE_COMPARATOR

Embolization, coiling

Intervention Type DEVICE

Endovascular embolization with platinum coils

Interventions

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Embolization, coiling

Endovascular embolization with platinum coils

Intervention Type DEVICE

Other Intervention Names

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Standard and bioactive coils

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Raymond, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal - Hôpital Notre-Dame

Andrew J. Molyneux, MD

Role: PRINCIPAL_INVESTIGATOR

NRU, Radcliffe Infirmary Oxford University UK

Allan J Fox, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre and University of Toronto

Claiborne S. Johnston, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco, USA

Jean-Paul Collet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia, Vancouver, Canada

Isabelle Rouleau, PhD

Role: PRINCIPAL_INVESTIGATOR

CHUM Hôpital Notre-Dame, Montreal, Canada

Locations

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St Joseph's Hospital & Medical Center

Phoenix, Arizona, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status

St Luke's-Roosevelt Hospital Center

New York, New York, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

The Methodist Hospital

Houston, Texas, United States

Site Status

CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office)

Montreal, Quebec, Canada

Site Status

TEAM France Coordination Unit - CHU Reims CRICAM

Reims, , France

Site Status

TEAM European Coordination Centre NVRU- Radcliffe Infirmary

Oxford, , United Kingdom

Site Status

Countries

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United States Canada France United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 17316800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17041525 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16484380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12775880 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20587222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18631395 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21330400 (View on PubMed)

Raymond J. Incidental intracranial aneurysms: rationale for treatment. Curr Opin Neurol. 2009 Feb;22(1):96-102. doi: 10.1097/wco.0b013e32831fee91.

Reference Type DERIVED
PMID: 19165956 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ISRCTN62758344

Identifier Type: REGISTRY

Identifier Source: secondary_id

MCT-80799

Identifier Type: -

Identifier Source: org_study_id