Randomized Trial Comparing PED Shield and Lattice Flow Diverter Devices for Treatment of Intracranial Aneurysms Assessing Ischemic and Clinical Outcomes

What this Trial Is About

Researchers are evaluating two surface-modified flow diverters, the Pipeline Flex Embolization Device with Shield Technology PED Shield and the Lattice Flow Diverter LFD, for treating unruptured intracranial aneurysms UIAs. The study aims to compare these devices in reducing ischemic complications after endovascular treatment, as there is limited comparative data between them. This prospective, multicenter randomized controlled trial will enroll 196 participants to assess differences in safety and effectiveness, focusing on ischemic event reduction. Participants will be randomly assigned to receive either the PED Shield or the LFD device during endovascular procedures. Both devices are implanted following standardized surgical techniques. Only one target aneurysm per patient will be treated with these flow diverters during the study. The primary outcome is the frequency of new positive lesions on diffusion-weighted imaging DWI of the brain within 48 hours after the procedure. Secondary outcomes include symptomatic ischemic events within 7 days, mortality and disability rates over approximately 6 months, delayed aneurysm rupture, aneurysm occlusion, and in-stent artery narrowing. During the study, participants will undergo brain MRI scans within 48 hours post-procedure to detect new ischemic lesions. Follow-up evaluations over six months will monitor neurological events, survival, disability, aneurysm status, and in-stent stenosis. All clinical data will be collected to measure the devices safety and efficacy. Participants must be between 18 and 75 years old, capable of informed consent, and able to complete follow-up visits. The trial is conducted without masking and uses a parallel randomized design.

Surface-Modified Flow Diverter for Intracranial Aneurysms: Assessment of Ischemic and Clinical Outcomes