International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)

Last updated: January 5, 2026
Sponsor: Montefiore Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

N/A

Clinical Study ID

NCT06174727
2023-15177
  • Ages > 18
  • All Genders

Study Summary

This multicenter retrospective cohort study aims to evaluate and compare the technical performance, safety, and clinical outcomes of intracranial aneurysms treated with flow diverter stents and endosaccular flow disruptors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (18 years of age or older)

  • Underwent endovascular treatment with one of the following devices: a. Endoluminal Flow Diverter Stents: i. Pipeline Flex (Covidien, California, USA)ii. Pipeline Flex with Shield Technology (Covidien) iii. Surpass Streamline (StrykerNeurovascular, California, USA) iv. Surpass Evolve (Stryker) v. Silk flow diverter (Balt Extrusion, Montmorency, France) vi. Flow-Redirection Intraluminal Device (FRED; MicroVention) vii. Flow-Redirection Intraluminal Device X (FRED X;MicroVention) viii. p64 Flow Modulation Device (phenox GmbH) ix. Endovascular clipsystem (eCLIPs) (eCLIPsTM, eVasc Neurovascular, Vancouver, BC, Canada) b. Intrasaccular Flow Disruptors: i. Woven EndoBridge (WEB; MicroVention) ii.Luna/Artisse System (Medtronic) iii. Medina Embolic Device (Medtronic) iv. ContourNeurovascular System (Cerus Endovascular) v. Neqstent Coil Assisted Flow Diverter (Cerus Endovascular) vi. pCONus and pCANvas (phenox GmbH) vii. Nexus AneurysmEmbolization System (EndoStream Medical) viii. CITADEL™ Embolization Device (Balt,USA)

  • Complete medical records and follow-up data available

Exclusion

Exclusion Criteria:

  • Incomplete procedural or follow-up records

  • Non-flow-diverter or non-flow-disruptor treatments (e.g., coiling-only cases)

  • Aneurysms treated with investigational devices not listed within Inclusion Criteria

Study Design

Total Participants: 5000
Study Start date:
October 01, 2023
Estimated Completion Date:
June 30, 2026

Study Description

Flow diverters and endosaccular flow disruptors used for the treatment of intracranial aneurysms exhibit distinct procedural and clinical outcomes, with potential differences in device-specific parameters such as procedure time, radiation exposure, adjunct device requirements, and long-term angiographic success. Since the completion of the Pipeline Embolization Device (PED) for the Intracranial Treatment of Aneurysms trial, the field of flow diversion has undergone continuous evolution with the development and approval of several devices. While these devices share a similar mechanism for aneurysm occlusion, their design and delivery systems can vary significantly. Various studies have demonstrated a promising safety and efficacy profile; however, the available data for a direct comparison of the technical and clinical outcomes between these devices remains limited.

Connect with a study center

  • Toronto Western Hospital

    Toronto 6167865, Ontario 6093943 M5T 2S8
    Canada

    Active - Recruiting

  • University of Miami

    Coral Gables 4151871, Florida 4155751 33146
    United States

    Active - Recruiting

  • Mayo Clinic Florida

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Completed

  • Sarasota Memorial Research Institute

    Sarasota 4172131, Florida 4155751 34239
    United States

    Active - Recruiting

  • Lahey Hospital and Medical Center

    Burlington 4931737, Massachusetts 6254926 01805
    United States

    Active - Recruiting

  • Munson Medical Center

    Traverse City 5012495, Michigan 5001836 49684
    United States

    Active - Recruiting

  • Robert Wood Johnson University

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Active - Recruiting

  • Montefiore Medical Center Department of Neurosurgery

    Bronx, New York 10467
    United States

    Site Not Available

  • University at Buffalo

    Buffalo 5110629, New York 5128638 14068
    United States

    Completed

  • Montefiore Medical Center Department of Neurosurgery

    The Bronx 5110266, New York 5128638 10467
    United States

    Active - Recruiting

  • Geisinger Health

    Danville 5186327, Pennsylvania 6254927 17822
    United States

    Completed

  • HCA Houston Healthcare Kingwood

    Kingwood 7534469, Texas 4736286 77339
    United States

    Completed

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