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

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Technical Success [Срок оценки: Periprocedurally, up to 24 hours]
• Procedural Complications following placement [Срок оценки: From the time of the procedure up to 1 month post treatment]
• Clinical Outcomes at Discharge [Срок оценки: Upon study discharge, up to 4 weeks]
• Clinical Outcomes at last available Follow-up [Срок оценки: Up to 24 months post procedure]
• Immediate Angiographic Outcomes at Discharge - O'Kelly-Marotta (OKM) grading scale [Срок оценки: Upon study discharge, up to 4 weeks]
• Immediate Angiographic Outcomes at Discharge - Modified Raymond-Roy Classification (mRRC) [Срок оценки: Upon study discharge, up to 4 weeks]
• Immediate Angiographic Outcomes at Discharge - WEB Occlusion Scale (WOS) [Срок оценки: Upon study discharge, up to 4 weeks]
• Angiographic Outcomes at last available Follow-up - O'Kelly-Marotta (OKM) grading scale [Срок оценки: Up to 24 months post procedure]
• Angiographic Outcomes at last available Follow-up - Modified Raymond-Roy Classification (mRRC) [Срок оценки: Up to 24 months post procedure]
• Angiographic Outcomes at last available Follow-up - WEB Occlusion Scale (WOS) [Срок оценки: Up to 24 months post procedure]

Вторичные конечные точки (5)

• Radiation Exposure [Срок оценки: Periprocedurally, up to 4 hours]
• Procedure Duration [Срок оценки: Periprocedurally, up to 4 hours]
• Use of Adjunct Devices [Срок оценки: Periprocedurally, up to 4 hours]
• Recurrence of Aneurysm [Срок оценки: 6 to 24 months post procedure]
• Aneurysm Retreatment [Срок оценки: 6 to 24 months post procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 11 центров

• 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
• … и ещё 3 центра

Канада · 2 центра

• St. Michael's Hospital — Toronto
• Toronto Western Hospital — Toronto

Публикации

• 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

Идентификаторы

NCT: NCT06174727 · 2023-15177

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗