Status:
NOT_YET_RECRUITING
Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial
Lead Sponsor:
Dr David Mathieu
Collaborating Sponsors:
Université de Sherbrooke
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 radio...
Detailed Description
This study is designed as a phase 2, two-arm, open label trial comparing a group undergoing stereotactic radiosurgery (SRS) to a control, observational group. Sample size This is a phase 2 safety an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06047951
Start Date
June 1 2025
End Date
June 1 2030
Last Update
February 14 2025
Active Locations (1)
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1
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4