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

Flow diverters (FDs) have become a mainstay of endovascular therapy for unruptured intracranial aneurysms (UIAs), yet their implantation carries an inherent risk of ischemic complications. The Pipeline Flex Embolization Device with Shield Technology (PED Shield) and the Lattice Flow Diverter (LFD) are two surface-modified FDs that have shown promising efficacy for mitigating procedure-related ischemic events in prior single-arm or retrospective series. Nevertheless, head-to-head comparative data between these two surface-modified flow diverters remain scarce, and prospective randomized clinical trials are warranted to corroborate their differential performance in lowering ischemic complication risks.This prospective, multicenter randomized controlled trial (RCT) was designed to compare the efficacy of PED Shield versus LFD in reducing ischemic complications after endovascular treatment of UIAs. A total of 196 eligible participants who meet the predefined inclusion and exclusion criteria will be enrolled in the trial. The primary outcome measure is the incidence of new diffusion-weighted imaging (DWI)-positive lesions on brain magnetic resonance imaging (MRI) within 48 hours after the procedure. The secondary outcome measures consist of perioperative symptomatic ischemic events, all-cause mortality and disability rate during the follow-up period, delayed aneurysm rupture at the 6-month follow-up, complete aneurysm occlusion rate, incidence of major in-stent stenosis (stenosis degree \>50%) at the 6-month follow-up, and the number of new DWI-positive lesions within 48 hours post-procedure.

NCT Number	NCT07674004
Lead Sponsor	Henan Provincial People's Hospital Collaborators: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Nanyang Central Hospital, First Hospital of China Medical University, Chinese PLA General Hospital, Yichang Central People's Hospital, Shandong First Medical University, Zhujiang Hospital, Handan Central Hospital, Kaifeng Central Hospital, The First Affiliated Hospital of Zhengzhou University
Conditions	Intracranial Aneurysms, Flow Diverter
Enrollment	196 participants
Start Date	2026-05-21
Primary Completion	2027-02-28 (estimated)
Study Completion	2027-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-01