Trial on Endovascular Aneurysm Management (TEAM)

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Terminated

Conditions: Brain Aneurysm

Treatments: Device: Embolization, coiling

Study type: Interventional

Funder types: Other

Identifiers

NCT00537134

ISRCTN62758344

MCT-80799

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Conservative

No Intervention group

Description:

Conservative management (watchful observation)

Endovascular

Active Comparator group

Description:

Endovascular treatment

Treatment:

Device: Embolization, coiling