Evaluating Safety and Effectiveness of Flow Diverters for Treating Intracranial Aneurysms in Adults

What this Trial Is About

Researchers are evaluating the clinical safety and effectiveness of Flow Diverters FD in treating intracranial aneurysms. This study aims to confirm how well FD works for aneurysms of different shapes and locations, optimize postoperative medication, and build a large database to support long-term treatment decisions. The trial will include 523 patients across multiple centers, focusing on real-world use of FD as a minimally invasive treatment to promote aneurysm healing. Participants will receive FD treatment, which works by changing blood flow to encourage clotting within the aneurysm and help repair blood vessels. This single-arm, prospective study involves follow-up evaluations at multiple time points, including 6 and 12 months after surgery. The study will assess aneurysm closure rates, success of the procedure, and any complications such as stroke or vessel narrowing. Researchers will also analyze surgery success rates and the need for retreatment. During the study, participants will undergo imaging tests like cerebral angiography and clinical assessments to monitor aneurysm healing and neurological function. Safety will be closely tracked through recording adverse events and neurological outcomes. Quality of life and functional recovery will also be evaluated. The entire participation period includes long-term follow-up to provide evidence supporting the use of FD and improving patient outcomes.

Clinical Safety and Efficacy of Flow-diverter in the Treatment of Intracranial Aneurysms