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Surveillance Versus Treatment of Unruptured Intracranial Aneurysms of Fortuitous Discovery
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
The goal of this clinical trial is to determine whether a watchful waiting strategy with imaging surveillance is superior to immediate aneurysm treatment in adults with incidentally discovered unruptured intracranial aneurysms (UIAs). The main questions it aims to answer are: * Does watchful waiting reduce the risk of clinically significant neurological disability compared with immediate treatment? * How do the two strategies compare in terms of aneurysm rupture, treatment-related complications, quality of life, anatomical outcomes, and healthcare costs? Researchers will compare two management strategies: * Immediate selective treatment of the aneurysm (endovascular or neurosurgical treatment according to standard practice). * Watchful waiting with regular clinical and imaging follow-up and no initial aneurysm treatment. Participants will: * Be randomly assigned to either immediate treatment or watchful waiting. * Undergo routine clinical assessments and annual brain imaging for at least 42 months. * Complete quality-of-life questionnaires (EQ-5D-5L) at baseline and annually during follow-up. * Participate in annual telephone follow-up assessments, including evaluation of functional outcome using the modified Rankin Scale (mRS). * Undergo a blood or urine pregnancy test at enrollment if they are women of childbearing potential. The study includes adults aged 35 years or older with incidentally discovered, non-infectious, intradural saccular UIAs measuring between 2.0 mm and 7.9 mm and no history of subarachnoid hemorrhage. The primary objective is to compare the impact of the two management strategies on neurological dependency during follow-up.
Official title: Surveillance Versus Treatment of Unruptured Intracranial Aneurysms of Fortuitous Discovery : a Randomized Controlled Trial STAF Trial
Key Details
Gender
All
Age Range
35 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2026-11
Completion Date
2033-05
Last Updated
2026-09-14
Healthy Volunteers
No
Interventions
Clinical and imaging surveillance
Participants undergo active surveillance of incidentally discovered unruptured intracranial aneurysms without initial preventive treatment. Management includes routine neurological follow-up and brain annual imaging according to routine clinical practice. Imaging consists of a 3D Time-of-Flight Magnetic Resonance Imaging (TOF MRI) sequence (or contrast-free CT (Computed-Tomography) and CT angiography of the circle of Willis in case of contraindications, and catheter angiogram with 3D if needed). Treatment will only be considered in the presence of predefined criteria suggestive of increased aneurysm related risk (e.g., aneurysm growth or clinical deterioration).
Endovascular or neurosurgical aneurysm treatment
Participants undergo immediate preventive treatment of the unruptured intracranial aneurysm according to standard clinical practice. Treatment modalities include endovascular procedures (e.g., coiling, stent-assisted coiling, flow diversion) or neurosurgical clipping, as determined by the treating physician. For patients with multiple aneurysms (≤7.9 mm), the operating investigator chooses at least one aneurysm to treat, while the treatment of any additional aneurysms is at the discretion of the team. Subsequent follow-up is performed according to standard clinical care (radiological follow-up at least annually, using the technique deemed most appropriate by the team). In case of recanalization, the choice and technique for additional treatment are left to the discretion of the team.
Locations (1)
Service de Neuroradiologie - Hôpital Lariboisière - APHP Nord
Paris, Île-de-France Region, France