Trial on Endovascular Aneurysm Management

Not Applicable

Terminated

Conditions: Brain Aneurysm

Interventions: Device: Embolization, coiling

Registration Number: NCT00537134

Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 80

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endovascular	Embolization, coiling	Endovascular treatment

Primary Outcome Measures

Name	Time	Method
Number of Participants With Disease or Treatment-related Morbidity and Mortality.	1 year after treatment or observation	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

Name	Time	Method
Measures on 36-Item Short-Form Health Survey (SF-36)	At 5 and 10 years	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 of the Aneurysm in the Conservative Group	At 5 and 10 years	To determine the rate of aneurysmal growth in the conservative group in surviving patients.
Number of Participants With Hemorrhage in Endovascular Group	At 1 year	Number of participants experiencing a hemorrhagic event despite successful treatment. This outcome measure gives an estimate of risk of rupture despite treatment
Modified Rankin Score	At 10 years	To compare overall Morbidity/Mortality of the 2 groups
Rate of Hemorrhage in Conservative Group	At 5 and 10 years	To better define the natural history of unruptured aneurysms eligible for endovascular treatment.
Number of Participants in Each Score of the Modified Rankin Scale in Endovascular Group	At 1 year	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.
Occlusion State in the Endovascular Group	At 5 and 10 years	To determine the rate of occlusion of aneurysms treated by coiling in an effort to estimate longer-term efficacy.
Number of Participants With a "Bad" Cognitive Function Evaluated According to the Montreal Cognitive Assessment Scale (MoCA)	Baseline, 1 year, 5 and 10 years	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

Trial Locations

Locations (9): St Joseph's Hospital & Medical Center
🇺🇸
Phoenix, Arizona, United States
Boston Medical Center
🇺🇸
Boston, Massachusetts, United States
St Luke's-Roosevelt Hospital Center
🇺🇸
New York, New York, United States
SUNY Downstate Medical Center
🇺🇸
Brooklyn, New York, United States
The Methodist Hospital
🇺🇸
Houston, Texas, United States
CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office)
🇨🇦
Montreal, Quebec, Canada
TEAM France Coordination Unit - CHU Reims CRICAM
🇫🇷
Reims, France
TEAM European Coordination Centre NVRU- Radcliffe Infirmary
🇬🇧
Oxford, United Kingdom
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States