Managing unruptured intracranial aneurysms with different treatment options
The Comprehensive Aneurysm Management Trial
This study is testing whether surgery or a less invasive treatment is better for people with unruptured brain aneurysms compared to just monitoring their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 6 sites (Edmonton, Alberta and 5 other locations) |
| Trial ID | NCT04155606 on ClinicalTrials.gov |
What this trial studies
This trial investigates the long-term clinical outcomes of patients with unruptured intracranial aneurysms (UIAs) who are offered either active treatment or conservative management. It aims to determine whether surgical clipping or endovascular treatment provides better outcomes compared to conservative management for patients deemed eligible for both surgical and endovascular options. The study addresses a significant gap in current medical practice, as there are no established guidelines or evidence supporting the treatment of UIAs. By offering a comprehensive framework for patient participation, the trial seeks to clarify the best management strategies for UIAs.
Who should consider this trial
Good fit: Ideal candidates include patients with at least one documented intracranial subarachnoid aneurysm who are considering treatment options.
Not a fit: Patients with recent intracranial hemorrhage or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide evidence-based guidelines for the treatment of unruptured intracranial aneurysms, potentially improving patient outcomes.
How similar studies have performed: While there have been no randomized trials comparing active and conservative management for UIAs, the study addresses a critical need in the field, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with at least one documented, intracranial subarachnoid aneurysm (cavernous aneurysms are excluded) Exclusion Criteria: * Patients with any intracranial hemorrhage, including SAH, within the previous 30 days * Patients with AVM-associated aneurysms * Patients unable to give informed consent
Where this trial is running
Edmonton, Alberta and 5 other locations
- University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
- Daniel Roy — Montreal, Quebec, Canada (Recruiting)
- Centre Hospitalier Régional Universitaire de Tours — Tours, France (Recruiting)
- ASST Ospedale Papa Giovanni XXIII — Bergamo, Italy (Recruiting)
- Ospedale Vito Frazzi — Lecce, Italy (Recruiting)
- Ospedale San Carlo Borromeo di Milano — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Tim Darsaut, MD — Neurosurgeon University of Alberta Health
- Study coordinator: Tim Darsaut, MD, MSc
- Email: tdarsaut@ualberta.ca
- Phone: 780-407-1440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.