Actively Recruiting
The Comprehensive Aneurysm Management Trial
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-07-28
2000
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
U
University of Alberta
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the best management of patients with unruptured intracranial aneurysms (UIAs), a condition where the optimal treatment approach remains uncertain after 30 years of study. This trial aims to compare active treatments like microsurgical clipping and endovascular interventions with conservative management to determine which provides better long-term outcomes. The study also addresses ethical concerns surrounding offering risky preventive treatments without proven benefits and strives to include all patients facing this clinical dilemma. The trial includes multiple groups where patients may receive either neurosurgery or endovascular procedures, such as coiling or stenting, or be monitored with pharmacological therapy if needed. Treatment decisions involve clinical judgment combined with randomized allocation to either active treatment or conservative management. Patients who undergo treatment will have follow-up visits approximately 6 to 12 weeks after treatment, then at 1, 5, and 10 years with imaging studies to monitor aneurysm status. Participants will be involved in long-term follow-up for 10 years, including clinical visits and imaging tests like CTA or MRA to assess aneurysm recurrence and overall health. Researchers will measure survival without neurological dependency as the primary outcome and secondary outcomes such as incidence of subarachnoid hemorrhage, treatment-related morbidity and mortality, overall mortality and morbidity at specific time points, length of hospitalization, and discharge location. The study is designed to gather comprehensive data on UIA management with minimal exclusions and broad inclusion criteria.
CONDITIONS
Brief Title
Comprehensive Aneurysm Management Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with at least one documented intracranial subarachnoid aneurysm (cavernous aneurysms are excluded)
You will not qualify if you...
- Patients with any intracranial hemorrhage, including subarachnoid hemorrhage, within the previous 30 days
- Patients with AVM-associated aneurysms
- Patients unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years of follow-up after treatment
Participants receive either neurosurgery or endovascular procedure as an active treatment for their unruptured intracranial aneurysms.
Clinic visits at approximately 6-12 weeks, 1 year, 5 years, and 10 years post-treatment; imaging at 12 ± 2 months post-treatment
Duration - Up to 10 years
Participants who undergo conservative management are monitored for aneurysm status and neurological outcomes over time.
Regular monitoring visits aligned with routine care; clinic visits at 1, 5, and 10 years
Trial Site Locations
Total: 6 locations
1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2R3
Actively Recruiting
2
Daniel Roy
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
3
Centre Hospitalier Régional Universitaire de Tours
Tours, France
Actively Recruiting
4
ASST Ospedale Papa Giovanni XXIII
Bergamo, Italy
Actively Recruiting
5
Ospedale Vito Frazzi
Lecce, Italy, 73100
Actively Recruiting
6
Ospedale San Carlo Borromeo di Milano
Milan, Italy
Actively Recruiting
Research Team
T
Tim Darsaut, MD, MSc
J
Jean Raymond, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2