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

N/AEnrolling By InvitationNCT05453240

Microvention-Terumo, Inc.250 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Intracranial Aneurysms

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: 1. 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; 2. 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

Locations (1)

Microvention

Aliso Viejo, California, United States

Outcomes

Primary Outcomes

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

Time frame: 5 year

Intracranial hemorrhage including SAH and IPH

Determined by adverse event adjudication by the clinical events committee

Time frame: 5 year

All ischemic and hemorrhagic stroke

Determined by adverse event adjudication by the clinical events committee

Time frame: 5 year

Neurological deaths

Determined by adverse event adjudication by the clinical events committee

Time frame: 5 year

Transient Ischemic Attack

Determined by adverse event adjudication by the clinical events committee

Time frame: 5 year

Parent artery patency

Determined by the corelab adjudication of images

Time frame: 5 year

In-stent stenosis

Determined by the corelab adjudication of images

Time frame: 5 year

Target aneurysm retreatment

Presented by the subject medical records

Time frame: 5 year

Cerebral vasospasm

Presented by the subject medical records

Data from ClinicalTrials.gov

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