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Recruiting NCT06174727

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

— Observational Intracranial Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Intracranial Aneurysm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Technical Success [Time frame: Periprocedurally, up to 24 hours]
  • Procedural Complications following placement [Time frame: From the time of the procedure up to 1 month post treatment]
  • Clinical Outcomes at Discharge [Time frame: Upon study discharge, up to 4 weeks]
  • Clinical Outcomes at last available Follow-up [Time frame: Up to 24 months post procedure]
  • Immediate Angiographic Outcomes at Discharge - O'Kelly-Marotta (OKM) grading scale [Time frame: Upon study discharge, up to 4 weeks]
  • Immediate Angiographic Outcomes at Discharge - Modified Raymond-Roy Classification (mRRC) [Time frame: Upon study discharge, up to 4 weeks]
  • Immediate Angiographic Outcomes at Discharge - WEB Occlusion Scale (WOS) [Time frame: Upon study discharge, up to 4 weeks]
  • Angiographic Outcomes at last available Follow-up - O'Kelly-Marotta (OKM) grading scale [Time frame: Up to 24 months post procedure]
  • Angiographic Outcomes at last available Follow-up - Modified Raymond-Roy Classification (mRRC) [Time frame: Up to 24 months post procedure]
  • Angiographic Outcomes at last available Follow-up - WEB Occlusion Scale (WOS) [Time frame: Up to 24 months post procedure]
Secondary outcome measures (5)
  • Radiation Exposure [Time frame: Periprocedurally, up to 4 hours]
  • Procedure Duration [Time frame: Periprocedurally, up to 4 hours]
  • Use of Adjunct Devices [Time frame: Periprocedurally, up to 4 hours]
  • Recurrence of Aneurysm [Time frame: 6 to 24 months post procedure]
  • Aneurysm Retreatment [Time frame: 6 to 24 months post procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 11 centers
  • University of Miami — Coral Gables
  • Mayo Clinic Florida — Jacksonville
  • Sarasota Memorial Research Institute — Sarasota
  • Lahey Hospital and Medical Center — Burlington
  • Munson Medical Center — Traverse City
  • Allina Health — Minneapolis
  • Robert Wood Johnson University — New Brunswick
  • University at Buffalo — Buffalo
  • … and 3 more centers
Canada · 2 centers
  • St. Michael's Hospital — Toronto
  • Toronto Western Hospital — Toronto

Publications

  • 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. PMID 21148256
  • 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. PMID 35580985
  • 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. PMID 25987590
  • 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. PMID 35669008
  • 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 N PMID 25125666
  • 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. PMID 20642887

Identifiers

NCT: NCT06174727 · 2023-15177

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗