Outcomes of Intra-arterial and Endosaccular Flow Diverters for Treatment of Intracranial Aneurysms - International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)

What this Trial Is About

Researchers are evaluating the technical performance, safety, and clinical outcomes of different devices used to treat intracranial aneurysms, specifically comparing flow diverter stents and endosaccular flow disruptors. These devices have distinct procedural and clinical profiles, and this observational study aims to provide a direct comparison of outcomes given the limited existing data. The study is sponsored by Montefiore Medical Center and includes adult patients treated with approved devices following the evolution of flow diversion technology. The study reviews records of patients treated with various flow diverter stents such as Pipeline Flex, Surpass Streamline, Silk flow diverter, and others, as well as intrasaccular flow disruptors like the Woven EndoBridge and Luna/Artisse System. It analyzes procedural details including radiation exposure, procedure duration, and the use of adjunct devices. Outcomes are assessed up to 24 months after treatment, focusing on angiographic results and clinical status at discharge and follow-up. Participants' medical records and follow-up data are collected to evaluate technical success, procedural complications, and clinical outcomes. Imaging outcomes are graded using scales such as the O'Kelly-Marotta grading scale and the Modified Raymond-Roy Classification. The study also tracks aneurysm recurrence and retreatment rates up to two years post-procedure. Safety is monitored from the time of the procedure through one month after treatment. The total participation involves retrospective review without active interventions or new treatments.

International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)