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

Summary

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.

Conditions

• Intracranial Aneurysms
• Flow Diverter

Interventions

DEVICE

LFD

Subjects who meet the inclusion and exclusion criteria will undergo randomization after signing the study informed consent form. When a subject is randomly assigned to the LFD group, the operator will implant this flow diverter following standardized surgical procedures.

DEVICE

PED Shield

Subjects who meet the inclusion and exclusion criteria will undergo randomization after signing the study informed consent form. When a subject is randomly assigned to the PED Shield group, the operator will implant this flow diverter following standardized surgical procedures.

Sponsors & Collaborators

• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  collaborator OTHER

• Nanyang Central Hospital

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Yichang Central People's Hospital

  collaborator OTHER

• Shandong First Medical University

  collaborator OTHER

• Zhujiang Hospital

  collaborator OTHER

• Handan Central Hospital

  collaborator OTHER

• Kaifeng Central Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Henan Provincial People's Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-21

Primary Completion

2027-02-28

Completion

2027-09-30

Countries

• China

Study Locations