Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial
Launched by DR DAVID MATHIEU · Sep 15, 2023
Trial Information
Current as of July 25, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial is a study focused on understanding whether a treatment called radiosurgery is safe and effective for people with certain types of brain aneurysms that have not yet caused any symptoms. An aneurysm is a weak spot in a blood vessel in the brain that can potentially rupture, leading to serious problems. In this trial, participants will have the option to choose whether they want to receive radiosurgery or just be monitored over time. Those who opt for the surgery will have it performed on the first day of the study, while those who choose not to will be closely observed without surgery.
To take part in this trial, participants need to have a specific type of small, unruptured brain aneurysm that is less than 7 mm and has been evaluated by a neurosurgeon who recommends observation instead of surgery. Throughout the study, both groups will have a series of follow-up appointments over three years, where they will undergo imaging tests and complete questionnaires to monitor their health and the condition of the aneurysm. The main goal of the trial is to see if radiosurgery affects the risk of the aneurysm rupturing, with the hope that it does not increase that risk.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Medical imaging (CTA, MRA or digital substraction angiography) reveals the existence of an asymptomatic unruptured saccular anterior circulation intracranial aneurysm under 7 mm
- • Advised by a vascular neurosurgeon to observe rather than undergo endovascular or microsurgical management
- Exclusion Criteria:
- • Prior history of aneurysmal rupture
- • Presence of symptoms that could be attributed to the aneurysm (severe headache, third cranial nerve deficits, or others)
- • Imaging features deemed to increase rupture risk as evaluated by the treating physician
- • Posterior circulation aneurysm
- • Fusiform aneurysm
- • Dissecting aneurysm
- • Mycotic aneurysm
- • Direct contact between the aneurysm and the optic pathways on medical imaging
- • Prior coils or clips in the targeted aneurysm or any other aneurysm
- • Patient unable to consent
- • Patient unable or unlikely to comply with the follow-up schedule
About Dr David Mathieu
Dr. David Mathieu is a distinguished clinical trial sponsor with a robust background in medical research and a commitment to advancing healthcare through innovative clinical studies. With extensive experience in designing and overseeing clinical trials, Dr. Mathieu ensures rigorous adherence to regulatory standards and ethical guidelines while fostering collaboration among multidisciplinary teams. His focus on patient-centered outcomes and the translation of scientific discoveries into practical treatments positions him as a leader in the field, dedicated to enhancing the efficacy and safety of therapeutic interventions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sherbrooke, Quebec, Canada
Patients applied
Trial Officials
David Mathieu, MD FRCS(C)
Principal Investigator
Service de neurochirurgie, Département de chirurgie, Centre hospitalier universitaire de Sherbrooke
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported