DERIVOae 2healae Study: Clinical Safety and Efficacy of the DERIVOae 2healae Embolisation Device for Intracranial Aneurysms

What this Trial Is About

Researchers are studying the clinical safety and effectiveness of the DERIVOae 2healae Embolisation Device used in treating intracranial aneurysms. This study is a prospective, single-arm, multicenter, open-label trial conducted in Germany to gather information on mid- and long-term clinical and angiographic outcomes. It aims to identify any risks and update the device's clinical evaluation to ensure its ongoing safety and performance after market approval. The study involves treating patients with the DERIVOae 2healae Embolisation Device as part of routine flow diversion therapy for intracranial aneurysms. Approximately 158 patients will be enrolled over 36 months across about 15 sites in Germany, with each patient followed for 12 months after treatment. Informed consent is obtained before or, in emergencies, shortly after the procedure. Data collected include technical success, safety, and clinical outcomes related to the device's use. Participants will be monitored through clinical evaluations at multiple time points including 6 weeks, 6 months, and 12 months after treatment. Researchers will assess primary safety, efficacy, and clinical endpoints, along with secondary outcomes measured immediately after treatment and at 12 months. Data are securely collected and monitored, with quality control steps ensuring accuracy. Results will be reported to ethics committees upon study completion.

DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device