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International Registry of Flow Diverter Stents

International Registry of Flow Diverter Stents

Recruiting
18 years and older
All
Phase N/A

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Overview

This multi-center retrospective cohort study aims to investigate the technical and clinical outcomes of intracranial aneurysms treated with Flow diverter stents.

Description

Flow diverters utilized for the treatment of intracranial aneurysms have outcomes such as shorter procedure times, less radiation exposure, less need for adjunct devices, and better angiographic outcomes. 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. Prior studies have demonstrated promising safety and efficacy profile; however, the available data for a direct comparison of the technical and clinical outcomes between these devices remains limited. This retrospective cohort study aims to investigate the technical and clinical outcomes of intracranial aneurysms treated with approved Flow diverter stents.

Eligibility

Inclusion Criteria:

  • Adult patients (18 years of age or older)
  • Prior completion of Endovascular intracranial flow diverter stent procedure using any of the following devices: Pipeline Flex (Covidien, California, USA), Pipeline Flex with Shield Technology (Covidien), Surpass Streamline (Stryker Neurovascular, California, USA), Surpass Evolve (Stryker), Silk flow diverter (SILK; Balt Extrusion, Montmorency, France), Flow-Redirection Intraluminal Device (FRED; MicroVention), Flow-Redirection Intraluminal Device X (FRED X; MicroVention), p64 Flow Modulation Device.

Exclusion Criteria:

  • Intracranial flow diversion procedure using a device not identified within the Inclusion Criteria

Study details
    Intracranial Aneurysm

NCT06174727

Montefiore Medical Center

28 January 2024

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