About this trial
The goal of this clinical trial is to confirm the feasibility and safety of performing radiosurgery on unruptured, low-risk aneurysms in humans.
Participants will choose if they want to undergo radiosurgery or not. Participants who choose not to have radiosurgery will be assigned to the observational group. Participants who choose to have radiosurgery performed will be assigned to the radiosurgery group. Participants in both groups will attend an initial exam session as well as four follow-up sessions:
Day 0
* Initial questionnaire * CTA scan * MRI * Radiosurgery performed on patients in the radiosurgery group
6 months * CTA scan * Follow-up questionnaire
12 months * CTA scan * MRI * Follow-up questionnaire
24 months * CTA scan * Follow-up questionnaire
36 months * CTA scan * MRI * Follow-up questionnaire
Researchers will compare the observational group and the radiosurgery group to see if there is a difference in the incidence of aneurysm rupture during the study period (3 years). The hypothesis is that radiosurgery should not increase the risk of aneurysm rupture.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Stereotactic RadioSurgery (SRS)
Treatment groups
Sponsors and collaborators
Dr David Mathieu
Lead sponsor
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor institution
Université de Sherbrooke
Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborator