Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device

Study Overview
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Brief Summary
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The proposed study is a multi-center single arm retrospective and prospective data collection, of patients treated with the LVIS device of specific sizes of 3.5mm, 4.0mm, 4.5mm, 5.5mm with up to 5 years follow-up. Information collected during the study will be standardized across centers to include pre-treatment baseline characteristics of patients including aneurysm(s) symptoms, procedural information, prespecified clinical safety events of interest, and follow-up imaging, clinical visits or telephone calls.

Official Title
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Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS® Device

Conditions
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Intracranial Aneurysms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The following criteria match the FDA-approved indications for use per PMA (P170013) Subjects treated with the LVIS® Device in accordance with currently approved indications for use; Treatment of wide-necked (neck ≥ 4mm or dome to neck ratio < 2) intracranial saccular aneurysm arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4.5 mm who underwent treatment with LVIS device of researched sizes within the last 5 years. (Device models: 212517-LVIS, 212525-LVIS, 213015-LVIS, 213025-LVIS, 213041-LVIS, 214035-LVIS, 214049-LVIS; 212912-LVIS, 212917-LVIS, 212922-LVIS, 212928-LVIS, and 212931-LVIS); Availability of Medical Health Records; Subject whose age is ≥ 18; Appropriate or Waived Consent: For retrospective review: Local Institutional Review Board approves the research as exempt, allowing an all-inclusive retrospective examination of medical records documenting treatments using the study devices and available clinical and imaging follow up; For prospective follow up: Subject or his/her Legally Authorized Representative consents to participation in the study follow up visits up to 5 years, and provides a signed informed consent form as applicable;. Exclusion Criteria: Subjects not treated according to the currently approved indications for use

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 |
| --- | --- | --- |
| Complete or Stable Raymond Roy II | The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. It is also known as the Raymond class, Montreal scale or the Raymond Montreal scale | 5 year | 
| Intracranial hemorrhage including SAH and IPH | Determined by adverse event adjudication by the clinical events committee | 5 year | 
| All ischemic and hemorrhagic stroke | Determined by adverse event adjudication by the clinical events committee | 5 year | 
| Neurological deaths | Determined by adverse event adjudication by the clinical events committee | 5 year | 
| Transient Ischemic Attack | Determined by adverse event adjudication by the clinical events committee | 5 year | 
| Parent artery patency | Determined by the corelab adjudication of images | 5 year | 
| In-stent stenosis | Determined by the corelab adjudication of images | 5 year | 
| Target aneurysm retreatment | Presented by the subject medical records | 5 year | 
| Cerebral vasospasm | Presented by the subject medical records | 5 year |