Intracranial aneurysm Circulatory System Intracranial aneurysm
Conditions
Interventions
Intervention group: Endovascular coiling of aneurysm, upon diagnosis
Control group: Conservative management/observation, upon diagnosis
Sponsors
Centre Hosp. de l'Université de Montréal (CHUM) (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least one documented subarachnoid aneurysm between 3 and 25 mm, never ruptured 2. Patient aged 18 or older, either sex 3. Life expectancy more than ten years
Exclusion criteria
Exclusion criteria: 1. Patients with intracranial haemorrhage 2. Lesion characteristics unsuitable for endovascular treatment 3. Patients with single cavernous aneurysms 4. Aneurysms less than 3 mm or giant aneurysms (more than or equal to 25 mm) 5. Patients with a poor outcome (Rankin scale more than or equal to three) after the rupture, surgical or endovascular treatment of another aneurysm 6. Patients with incompletely treated aneurysms that have previously ruptured 7. Patients with associated arteriovenous malformations 8. 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) 9. Patients with previous intracranial haemorrhage from unknown aetiology 10. Patients with multiple unruptured aneurysms in whom surgical clipping of one or many aneurysms is planned in addition to endovascular management 11. Patients with absolute contraindications to anaesthesia, endovascular treatment, or administration of contrast material, including low-osmolarity agents or gadolinium 12. Pregnant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease or treatment-related morbidity and mortality, measured at one year, five and ten years after treatment or observation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To better define the natural history of unruptured aneurysms eligible for endovascular treatment, measured at five and ten years 2. Define the rate of haemorrhagic events despite endovascular treatment at one year, five and ten years 3. Determine the M/M related to endovascular treatment of unruptured aneurysms at one year, five and ten years 4. Compare overall M/M of the two groups at ten years 5. Compare the quality of life and anxiety levels of surviving patients of the two groups at five and ten years 6. Determine the rate of occlusion of aneurysms treated by coiling in an effort to estimate longer-term efficacy at five and ten years 7. Determine the rate of aneurysmal growth in the conservative group in surviving patients at five and ten years 8. Verify cognitive functions using the Montreal Cognitive Assessment (MoCA) in all patients at baseline, one year, five and ten years; as well as by detailed neuropsychological testing at baseline and six months after treatment in a consecutive sample of 100 patients of both groups | — |
Countries
Australia, Canada, Chile, China, Czech Republic, France, Germany, Greece, Italy, Norway, Russian Federation, Spain, Switzerland, Turkey, United Kingdom, United States of America
Contacts
Public ContactGuylaine Gevry
Outcome results
None listed