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

Last updated: January 16, 2025
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. Flow Diverter Stents: i. Pipeline Flex (Covidien, California, USA) ii. PipelineFlex 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). b. Endosaccular 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:
December 31, 2025

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

  • Montefiore Medical Center Department of Neurosurgery

    Bronx, New York 10467
    United States

    Active - Recruiting

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