NCT06174727Recruiting

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

Montefiore Medical Center

Start Date

10/1/2023

Completion Date

7/1/2027

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Consecutive 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 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

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Conditions

Intracranial Aneurysm

Locations

University of Miami

Coral Gables, Florida 33146

United States

Mayo Clinic Florida

Jacksonville, Florida 32224

United States

Sarasota Memorial Research Institute

Sarasota, Florida 34239

United States

Lahey Hospital and Medical Center

Burlington, Massachusetts 01805

United States

Munson Medical Center

Traverse City, Michigan 49684

United States

Allina Health

Minneapolis, Minnesota 55404

United States

Robert Wood Johnson University

New Brunswick, New Jersey 08901

United States

University at Buffalo

Buffalo, New York 14068

United States

Montefiore Medical Center Department of Neurosurgery

The Bronx, New York 10467

United States

Geisinger Health

Danville, Pennsylvania 17822

United States

HCA Houston Healthcare Kingwood

Kingwood, Texas 77339

United States

St. Michael's Hospital

Toronto, Ontario M5B 1W8

Canada

Toronto Western Hospital

Toronto, Ontario M5T 2S8

Canada