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

NCT ID: NCT06174727

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Intracranial Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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 (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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

Simpson Memorial Research Institute

OTHER

Sponsor Role collaborator

Geisinger Health

UNKNOWN

Sponsor Role collaborator

University at Buffalo

OTHER

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Altschul, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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University of Miami

Coral Gables, Florida, United States

Site Status RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status COMPLETED

Sarasota Memorial Research Institute

Sarasota, Florida, United States

Site Status RECRUITING

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Site Status RECRUITING

Munson Medical Center

Traverse City, Michigan, United States

Site Status RECRUITING

Robert Wood Johnson University

New Brunswick, New Jersey, United States

Site Status RECRUITING

University at Buffalo

Buffalo, New York, United States

Site Status COMPLETED

Montefiore Medical Center Department of Neurosurgery

The Bronx, New York, United States

Site Status RECRUITING

Geisinger Health

Danville, Pennsylvania, United States

Site Status COMPLETED

HCA Houston Healthcare Kingwood

Kingwood, Texas, United States

Site Status COMPLETED

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Muhammed Amir Essibayi, MD

Role: CONTACT

347-908-1889

Facility Contacts

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Robert Starke, MD, MS

Role: primary

305-355-1101

Eyad Almallouhi, MD

Role: primary

941-917-7191

Timo Krings, MD, PhD, MSc

Role: primary

781-744-3330

Amy Peterson, PhD

Role: primary

231-935-6746

Gaurav Gupta, MD

Role: primary

732-235-6333

Muhammed Amir Essibayi, MD

Role: primary

347-908-1889

David Altschul, MD

Role: backup

(718) 920-7498

Pascal Mosimann, MD

Role: primary

416-603 5800

References

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Nelson PK, Lylyk P, Szikora I, Wetzel SG, Wanke I, Fiorella D. The pipeline embolization device for the intracranial treatment of aneurysms trial. AJNR Am J Neuroradiol. 2011 Jan;32(1):34-40. doi: 10.3174/ajnr.A2421. Epub 2010 Dec 9.

Reference Type BACKGROUND
PMID: 21148256 (View on PubMed)

Hecker C, Broussalis E, Griessenauer CJ, Killer-Oberpfalzer M. A mini-review of intrasaccular flow diverters. J Neurointerv Surg. 2023 Jan;15(1):70-74. doi: 10.1136/neurintsurg-2021-018426. Epub 2022 May 17.

Reference Type BACKGROUND
PMID: 35580985 (View on PubMed)

Colby GP, Lin LM, Caplan JM, Jiang B, Michniewicz B, Huang J, Tamargo RJ, Coon AL. Flow diversion of large internal carotid artery aneurysms with the surpass device: impressions and technical nuance from the initial North American experience. J Neurointerv Surg. 2016 Mar;8(3):279-86. doi: 10.1136/neurintsurg-2015-011769. Epub 2015 May 18.

Reference Type BACKGROUND
PMID: 25987590 (View on PubMed)

Vivanco-Suarez J, Feigen C, Javed K, Dardick JM, Holland R, Mendez-Ruiz A, Ortega-Gutierrez S, Haranhalli N, Altschul DJ. Dataset on flow diversion procedures performed with the Pipeline Embolization Device, Pipeline Flex, and Surpass Streamline for intracranial aneurysms. Data Brief. 2022 May 21;42:108299. doi: 10.1016/j.dib.2022.108299. eCollection 2022 Jun.

Reference Type BACKGROUND
PMID: 35669008 (View on PubMed)

Wakhloo AK, Lylyk P, de Vries J, Taschner C, Lundquist J, Biondi A, Hartmann M, Szikora I, Pierot L, Sakai N, Imamura H, Sourour N, Rennie I, Skalej M, Beuing O, Bonafe A, Mery F, Turjman F, Brouwer P, Boccardi E, Valvassori L, Derakhshani S, Litzenberg MW, Gounis MJ; Surpass Study Group. Surpass flow diverter in the treatment of intracranial aneurysms: a prospective multicenter study. AJNR Am J Neuroradiol. 2015 Jan;36(1):98-107. doi: 10.3174/ajnr.A4078. Epub 2014 Aug 14.

Reference Type BACKGROUND
PMID: 25125666 (View on PubMed)

O'kelly CJ, Krings T, Fiorella D, Marotta TR. A novel grading scale for the angiographic assessment of intracranial aneurysms treated using flow diverting stents. Interv Neuroradiol. 2010 Jun;16(2):133-7. doi: 10.1177/159101991001600204. Epub 2010 Jul 19.

Reference Type BACKGROUND
PMID: 20642887 (View on PubMed)

Other Identifiers

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2023-15177

Identifier Type: -

Identifier Source: org_study_id

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