Status:
COMPLETED
The Canadian UnRuptured Endovascular Versus Surgery Trial (CURES)
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
University of Alberta
Conditions:
Intracranial Aneurysms
Eligibility:
All Genders
18+ years
Brief Summary
Purpose: Phase 1: (Pilot Phase) To compare the treatment efficacy of surgical clipping and endovascular coiling for unruptured intracranial aneurysms. To obtain better estimates of morbidity and mo...
Eligibility Criteria
Inclusion
- Patients at least 18 years of age with at least 10 years of remaining life expectancy
- At least one documented, intradural, saccular intracranial aneurysm
- The patient and aneurysm are considered appropriate for either surgical or endovascular treatment by the treating team
- Aneurysm size 3-25 mm
Exclusion
- Patients with any intracranial hemorrhage, including SAH, within the previous 30 days
- Lesion characteristics not readily suitable for either endovascular or surgical treatment, in the opinion of the physician(s) intending to treat the aneurysm
- Multiple aneurysms, where the treatment plan includes both surgical clipping as well as endovascular coiling
- Aneurysm anticipated (pre-operatively) to require proximal vessel occlusion, a bypass, or other flow-redirecting therapy (such as flow-diverting stents) as part of treatment plan
- Patients with baseline mRS \>2
- Patients with a single cavernous aneurysm
- Patients with dissecting, fusiform, or mycotic aneurysms
- Patients with AVM-associated aneurysms
- Pregnant patients (randomization (and treatment) may be delayed until after delivery)
- Patients with absolute contraindications to anaesthesia, endovascular treatment or administration of contrast material, including low-osmolarity agents or gadolinium
- Patients unable to give informed consent
Key Trial Info
Start Date :
September 26 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT01139892
Start Date
September 26 2010
End Date
October 1 2022
Last Update
July 6 2023
Active Locations (6)
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1
Centre hospitalier universitaire de Liège
Liège, Belgium
2
Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9
3
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
4
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6