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

29. juni 2026 oppdatert av: Henan Provincial People's Hospital

Prospective Randomized Controlled Trial of Surface-Modified Flow Diverter for Intracranial Aneurysms: Multicenter 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

196

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Henan
      • Zhengzhou, Henan, Kina, 450000
        • Rekruttering
        • Henan Provincial People's Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. 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).
  2. 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.
  3. The target aneurysm was treated solely with flow diverter (FD) implantation in the current study.
  4. The age of enrolled patients ranged from 18 to 75 years old.
  5. 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:

  1. Patients with a prior history of endovascular treatment for the target aneurysm.
  2. Patients in the acute stage of cerebrovascular diseases (acute cerebral infarction or intracerebral hemorrhage with an onset time of ≤ 2 weeks).
  3. Patients complicated with other cerebrovascular disorders, including moyamoya disease, cerebrovascular malformations, and arteriovenous fistula.
  4. 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).
  5. Patients with a preoperative modified Rankin Scale (mRS) score greater than 2.
  6. Patients with any absolute contraindications to device treatment as specified in the Instructions for Use (IFU).
  7. Patients enrolled in other clinical trials that may interfere with the primary or secondary endpoints of the present study.
  8. Patients with comorbidities that may interfere with neurological function evaluation, affect survival status, or impair the ability to complete follow-up visits.
  9. Pregnant or lactating female patients.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: PED Shield
Subjects Treated with the PED Shield for Intracranial Aneurysms
Enhet: 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.
Eksperimentell: LFD
Subjects Treated with the LFD for Intracranial Aneurysms
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The incidence of patients with new positive diffusion-weighted imaging (DWI) lesions
Tidsramme: 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.
Within 48 Hours postoperatively.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Symptomatic neurological ischemic events
Tidsramme: 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.
0-7 days postoperatively
Mortality and major disability rate during follow-up
Tidsramme: 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.
180 (±30) days
Rate of delayed aneurysm rupture
Tidsramme: 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.
180 (±30) days
Aneurysm complete occlusion rate
Tidsramme: 180 (±30) days
Complete occlusion rate of the target aneurysm assessed via the Raymond-Roy classification scale.
180 (±30) days
Incidence of target parent artery in-stent stenosis (>50%)
Tidsramme: 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.
180 (±30) days
Number of DWI positive lesions
Tidsramme: Within 48 hours postoperatively
The number of DWI positive lesions detected on postoperative magnetic resonance imaging (MRI).
Within 48 hours postoperatively

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Henan Provincial People's Hospital

Samarbeidspartnere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. mai 2026

Primær fullføring (Antatt)

28. februar 2027

Studiet fullført (Antatt)

30. september 2027

Datoer for studieregistrering

Først innsendt

23. juni 2026

Først innsendt som oppfylte QC-kriteriene

23. juni 2026

Først lagt ut (Faktiske)

29. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025-234

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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