International Registry of Flow Diverter Stents (IRF)

Study Overview
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Brief Summary
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This multi-center retrospective cohort study aims to investigate the technical and clinical outcomes of intracranial aneurysms treated with Flow diverter stents.

Detailed Description
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Flow diverters utilized for the treatment of intracranial aneurysms have outcomes such as shorter procedure times, less radiation exposure, less need for adjunct devices, and better angiographic outcomes. 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. Prior studies have demonstrated promising safety and efficacy profile; however, the available data for a direct comparison of the technical and clinical outcomes between these devices remains limited. This retrospective cohort study aims to investigate the technical and clinical outcomes of intracranial aneurysms treated with approved Flow diverter stents.

Official Title
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Outcomes of Flow Diverters for Treatment of Intracranial Aneurysms - International Registry of Flow Diverter Stents (IRF)

Conditions
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Intracranial Aneurysm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (18 years of age or older) Prior completion of Endovascular intracranial flow diverter stent procedure using any of the following devices: Pipeline Flex (Covidien, California, USA), Pipeline Flex with Shield Technology (Covidien), Surpass Streamline (Stryker Neurovascular, California, USA), Surpass Evolve (Stryker), Silk flow diverter (SILK; Balt Extrusion, Montmorency, France), Flow-Redirection Intraluminal Device (FRED; MicroVention), Flow-Redirection Intraluminal Device X (FRED X; MicroVention), p64 Flow Modulation Device. Exclusion Criteria: Intracranial flow diversion procedure using a device not identified within the Inclusion Criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Complications following placement of Flow Diverter Stents | Complications will be identified as the number of instances of the following adverse clinical events: In-stent Thrombosis/Stenosis; Ischemic complications (Transient Ischemic Attack/Stroke), Intracerebral hemorrhage, Aneurysm rupture, and Vessel occlusion due to stent placement. | From the time of the procedure up to 1 month post treatment | 
| Clinical Outcomes on Discharge | Clinical outcomes at discharge will be assessed using the modified Rankin Scale (mRS) for neurologic disability. The mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a favorable outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an unfavorable outcome. | Upon study discharge, up to 4 weeks | 
| Immediate Angiographic Outcomes on Discharge | The O'Kelly-Marotta (OKM) grading scale will be used to assess the degree of angiographic filling and in the setting of intracranial aneurysms which were treated by endovascular flow diversion. It is used to predict aneurysm closure over time. Patient outcomes will be stratified based on the following scale scores: Grade A: Total filling (>95% of aneurysm remained); Grade B: Subtotal filling (5-95% of aneurysm remained); Grade C: Entry remnant (<5% aneurysm remained); and Grade D: No filling (0% aneurysm remained). As such, the less aneurysm remnant the more favorable the angiographic outcome. | Upon study discharge, up to 4 weeks | 
| Clinical Outcomes at Follow-up | Clinical outcomes at follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a favorable outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an unfavorable outcome. Scoring will also include a 6 to identify patients who have expired. | Up to 24 months post procedure | 
| Angiographic Outcomes at Follow-up | The O'Kelly-Marotta (OKM) grading scale will be used to assess the degree of angiographic filling and in the setting of intracranial aneurysms which were treated by endovascular flow diversion. It is used to predict aneurysm closure over time. Patient outcomes will be stratified based on the following scale scores: Grade A: Total filling (>95% of aneurysm remained); Grade B: Subtotal filling (5-95% of aneurysm remained); Grade C: Entry remnant (<5% aneurysm remained); and Grade D: No filling (0% aneurysm remained). As such, the less aneurysm remnant the more favorable the angiographic outcome. | Up to 24 months post procedure | 
| Recurrence of Aneurysm | The percentage of patients who experienced a recurrence of aneurysm will be recorded | 6 to 24 months post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Registry, Flow Diversion, Endovascular