RecruitingNCT06174727

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

Outcomes of Intra-arterial and Endosaccular Flow Diverters for Treatment of Intracranial Aneurysms - International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)

Sponsor

Montefiore Medical Center

Enrollment

5,000 participants

Start Date

Oct 1, 2023

Study Type

OBSERVATIONAL

Conditions

Intracranial Aneurysm

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

Min Age: 18 Years

Inclusion Criteria5

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 (Stryker Neurovascular, 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 clip system (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. Contour Neurovascular System (Cerus Endovascular) v. Neqstent Coil Assisted Flow Diverter (Cerus Endovascular) vi. pCONus and pCANvas (phenox GmbH) vii. Nexus Aneurysm Embolization System (EndoStream Medical) viii. CITADEL™ Embolization Device (Balt, USA)
Complete medical records and follow-up data available

Exclusion Criteria2

Incomplete procedural or follow-up records
Non-flow-diverter or non-flow-disruptor treatments (e.g., coiling-only cases)

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Locations(11)

University of Miami

Coral Gables, Florida, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Sarasota Memorial Research Institute

Sarasota, Florida, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Munson Medical Center

Traverse City, Michigan, United States

Robert Wood Johnson University

New Brunswick, New Jersey, United States

University at Buffalo

Buffalo, New York, United States

Montefiore Medical Center Department of Neurosurgery

The Bronx, New York, United States

Geisinger Health

Danville, Pennsylvania, United States

HCA Houston Healthcare Kingwood

Kingwood, Texas, United States

Toronto Western Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06174727

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