Comprehensive Study Comparing Surgery, Endovascular Treatment, and Monitoring for Unruptured Brain Aneurysms

What this Trial Is About

Researchers are evaluating the best management of patients with unruptured intracranial aneurysms UIAs, a condition where the optimal treatment approach remains uncertain after 30 years of study. This trial aims to compare active treatments like microsurgical clipping and endovascular interventions with conservative management to determine which provides better long-term outcomes. The study also addresses ethical concerns surrounding offering risky preventive treatments without proven benefits and strives to include all patients facing this clinical dilemma. The trial includes multiple groups where patients may receive either neurosurgery or endovascular procedures, such as coiling or stenting, or be monitored with pharmacological therapy if needed. Treatment decisions involve clinical judgment combined with randomized allocation to either active treatment or conservative management. Patients who undergo treatment will have follow-up visits approximately 6 to 12 weeks after treatment, then at 1, 5, and 10 years with imaging studies to monitor aneurysm status. Participants will be involved in long-term follow-up for 10 years, including clinical visits and imaging tests like CTA or MRA to assess aneurysm recurrence and overall health. Researchers will measure survival without neurological dependency as the primary outcome and secondary outcomes such as incidence of subarachnoid hemorrhage, treatment-related morbidity and mortality, overall mortality and morbidity at specific time points, length of hospitalization, and discharge location. The study is designed to gather comprehensive data on UIA management with minimal exclusions and broad inclusion criteria.

Comprehensive Aneurysm Management Trial