Trial on Endovascular Aneurysm Management

NCT00537134 | Terminated Results DMC

• 2 other identifiers: MCT-80799ISRCTN62758344
• Study Type: interventional
• Target: 80
• Locations: 4 countries
• Sites: 9

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.

Conditions

Brain Aneurysm

Keywords

Aneurysm; Brain; Unruptured; observation; treatment; Endovascular

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Rate of Hemorrhage in Conservative Group

  At 5 and 10 years

• Number of Participants With Hemorrhage in Endovascular Group

  At 1 year

• Number of Participants in Each Score of the Modified Rankin Scale in Endovascular Group

  At 1 year

• Modified Rankin Score

  At 10 years

• Measures on 36-Item Short-Form Health Survey (SF-36)

  At 5 and 10 years

Study Arms (2)

Conservative

NO INTERVENTION

Conservative management (watchful observation)

Endovascular

ACTIVE COMPARATOR

Endovascular treatment

Device: Embolization, coiling

Interventions

Embolization, coiling DEVICE

Endovascular embolization with platinum coils

Also known as: Standard and bioactive coils

Endovascular

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one documented subarachnoid aneurysm, never ruptured
• Patient aged 18 or older
• Life expectancy more than 10 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (9)

St Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

St Luke's-Roosevelt Hospital Center

New York, New York, 10029-6504, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

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

Montreal, Quebec, H2L 4M1, Canada

Location

TEAM France Coordination Unit - CHU Reims CRICAM

Reims, France

Location

TEAM European Coordination Centre NVRU- Radcliffe Infirmary

Oxford, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 17316800 BACKGROUND

• 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.

  PMID: 17041525 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.

  PMID: 16484380 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.

  PMID: 12775880 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.

  PMID: 20587222 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.

  PMID: 18631395 BACKGROUND

• 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.

  PMID: 21330400 DERIVED

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

  PMID: 19165956 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Limitations and Caveats

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

Results Point of Contact

• Title: Ruby Klink
• Organization: Centre Hospitalier de l'Université de Montréal (CHUM)

ruby.klink.chum@ssss.gouv.qc.ca

(514) 890-8000

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2007
• First Posted: September 28, 2007
• Study Start: April 1, 2006
• Primary Completion: June 28, 2009
• Study Completion: July 1, 2009
• Last Updated: December 30, 2022
• Results First Posted: December 30, 2022

Record last verified: 2022-12

Locations

GB (1); FR (1); US (6); CA (1)