Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07674004

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Intracranial Aneurysms Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Flow Diverter Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location status: Recruiting

Location contact

Li Li, MD

CONTACT

[email protected]

+8615038063905

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients were diagnosed with unruptured intracranial aneurysms, and the lesions were evaluated to be suitable for endovascular treatment with flow diverter devices (PED Shield/Lattice).
  • During the study period, only one target aneurysm per patient was treated, with the exception of segmental lesions, in which multiple aneurysms located within the same arterial segment were treated with a single or overlapping study devices.
  • The target aneurysm was treated solely with flow diverter (FD) implantation in the current study.
  • The age of enrolled patients ranged from 18 to 75 years old.
  • Patients were capable of understanding the study-related informed consent information and provided written informed consent for the use of their clinical data for research purposes.

Exclusion criteria

  • Patients with a prior history of endovascular treatment for the target aneurysm.
  • Patients in the acute stage of cerebrovascular diseases (acute cerebral infarction or intracerebral hemorrhage with an onset time of ≤ 2 weeks).
  • Patients complicated with other cerebrovascular disorders, including moyamoya disease, cerebrovascular malformations, and arteriovenous fistula.
  • Patients with atherosclerotic changes in the parent artery of the target aneurysm that necessitated additional intraoperative endovascular interventions (e.g., balloon angioplasty or conventional stent implantation).
  • Patients with a preoperative modified Rankin Scale (mRS) score greater than 2.
  • Patients with any absolute contraindications to device treatment as specified in the Instructions for Use (IFU).
  • Patients enrolled in other clinical trials that may interfere with the primary or secondary endpoints of the present study.
  • Patients with comorbidities that may interfere with neurological function evaluation, affect survival status, or impair the ability to complete follow-up visits.
  • Pregnant or lactating female patients.

Treatment and study plan

LFD

Device

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.

PED Shield

Device

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.

Primary outcomes

  1. The incidence of patients with new positive diffusion-weighted imaging (DWI) lesions

    Time frame: Within 48 Hours postoperatively.

    The proportion of patients with newly developed DWI hyperintensities detected on magnetic resonance imaging (MRI) within 48 hours after the surgical procedure.

Secondary outcomes

  1. Symptomatic neurological ischemic events

    Time frame: 0-7 days postoperatively

    Symptomatic neurological ischemic events related to the target aneurysm, mainly including transient ischemic attack （TIA） and acute cerebral infarction, as adjudicated by the clinical event committee.

  2. Mortality and major disability rate during follow-up

    Time frame: 180 (±30) days

    Proportion of patients with a modified Rankin Scale (mRS) score > 3 or an increase of ≥ 2 points in mRS score from baseline, as adjudicated by the clinical event committee.

  3. Rate of delayed aneurysm rupture

    Time frame: 180 (±30) days

    Incidence of intracranial hemorrhage caused by delayed rupture of the target aneurysm, as adjudicated by the clinical event committee. The time calculation starts from the first day after surgery.

  4. Aneurysm complete occlusion rate

    Time frame: 180 (±30) days

    Complete occlusion rate of the target aneurysm assessed via the Raymond-Roy classification scale.

  5. Incidence of target parent artery in-stent stenosis (>50%)

    Time frame: 180 (±30) days

    In-stent stenosis of the target parent artery was defined as stenosis degree >50%, which was evaluated by digital subtraction angiography (DSA), computed tomography angiography (CTA), or magnetic resonance angiography (MRA) at 6 months after surgery.

  6. Number of DWI positive lesions

    Time frame: Within 48 hours postoperatively

    The number of DWI positive lesions detected on postoperative magnetic resonance imaging (MRI).

Study contacts

Contact information is provided by the study sponsor or research team.

Li Li, MD

CONTACT

[email protected]

+8615038063905

Sponsors and collaborators

Lead sponsor

Henan Provincial People's Hospital

Other

Collaborators

  • Chinese PLA General Hospital
  • First Hospital of China Medical University
  • Handan Central Hospital
  • Kaifeng Central Hospital
  • Nanyang Central Hospital
  • Shandong First Medical University
  • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Zhengzhou University
  • Yichang Central People's Hospital
  • Zhujiang Hospital

Registry information

Official study title

Prospective Randomized Controlled Trial of Surface-Modified Flow Diverter for Intracranial Aneurysms: Multicenter Assessment of Ischemic and Clinical Outcomes

Acronym: PRISMATIC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.