Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry

What this Trial Is About

Researchers are studying the best ways to manage patients with brain arteriovenous malformations (AVMs), whether these AVMs have caused bleeding (ruptured) or not (unruptured). The study aims to compare medical (conservative) management with interventional treatments like neurosurgery, radiation therapy, radiosurgery, and endovascular procedures to see which approach better reduces the risk of death or disabling stroke over 10 years. There is also a nested trial to evaluate whether embolization before surgery or radiosurgery improves treatment success and safety. The interventional therapies studied include surgical removal of the AVM when it is safely operable, radiation therapy for smaller AVMs less than 3 cm that cannot be safely operated on, radiosurgery, and curative embolization. Patients judged by a multidisciplinary team to possibly benefit from endovascular treatment before surgery or radiation may be randomly assigned to receive embolization or not. The conservative group receives medical management for symptoms, and if bleeding or infarction occurs, they may become candidates for interventional therapy. Participants will be followed for up to 10 years to monitor outcomes such as death from any cause or disabling stroke, measured by the Rankin Scale. The study will track neurological events, treatment complications, and the success of AVM occlusion. Researchers will regularly assess participants' neurological status and adverse events. This long-term follow-up aims to provide clearer guidance on the safest and most effective management strategies for brain AVMs.

Treatment of Brain AVMs (TOBAS) Study