Clinical trial NCT06174727: International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Aneurysm
Keywords: Endovascular
Registry
Flow Diverter Stents
Endosaccular Flow Disruptors
Flow Diversion
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Simpson Memorial Research Institute
name: Geisinger Health
name: University at Buffalo
name: Thomas Jefferson University
First posted: 2023-12-18
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intracranial aneurysms who underwent endovascular treatment with flow diverter stents or endosaccular flow disruptors

Brief 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: Inclusion Criteria:

* Adult patients (18 years of age or older)
* Underwent endovascular treatment with one of the following devices:

  a. 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).

  b. Endosaccular 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

Primary outcomes:
measure: Procedural Complications following placement
timeFrame: From the time of the procedure up to 1 month post treatment
measure: Clinical Outcomes at Discharge
timeFrame: Upon study discharge, up to 4 weeks
measure: Clinical Outcomes at last available Follow-up
timeFrame: Up to 24 months post procedure
measure: Immediate Angiographic Outcomes at Discharge - O'Kelly-Marotta (OKM) grading scale
timeFrame: Upon study discharge, up to 4 weeks
measure: Immediate Angiographic Outcomes at Discharge - Modified Raymond-Roy Classification (mRRC)
timeFrame: Upon study discharge, up to 4 weeks
measure: Immediate Angiographic Outcomes at Discharge - WEB Occlusion Scale (WOS)
timeFrame: Upon study discharge, up to 4 weeks
measure: Angiographic Outcomes at last available Follow-up - O'Kelly-Marotta (OKM) grading scale
timeFrame: Up to 24 months post procedure
measure: Angiographic Outcomes at last available Follow-up - Modified Raymond-Roy Classification (mRRC)
timeFrame: Up to 24 months post procedure
measure: Angiographic Outcomes at last available Follow-up - WEB Occlusion Scale (WOS)
timeFrame: Up to 24 months post procedure
measure: Technical Success
timeFrame: Periprocedurally, up to 24 hours
Secondary outcomes:
measure: Radiation Exposure
timeFrame: Periprocedurally, up to 4 hours
measure: Procedure Duration
timeFrame: Periprocedurally, up to 4 hours
measure: Use of Adjunct Devices
timeFrame: Periprocedurally, up to 4 hours
measure: Recurrence of Aneurysm
timeFrame: 6 to 24 months post procedure
measure: Aneurysm Retreatment
timeFrame: 6 to 24 months post procedure
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center Department of Neurosurgery
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: David Altschul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.