Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS® Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Aneurysms
- Sponsor
- Microvention-Terumo, Inc.
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Transient Ischemic Attack
- Status
- Enrolling By Invitation
- Last Updated
- 10 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Transient Ischemic Attack
Time Frame: 5 year
Determined by adverse event adjudication by the clinical events committee
Cerebral vasospasm
Time Frame: 5 year
Presented by the subject medical records
Intracranial hemorrhage including SAH and IPH
Time Frame: 5 year
Determined by adverse event adjudication by the clinical events committee
Neurological deaths
Time Frame: 5 year
Determined by adverse event adjudication by the clinical events committee
Complete or Stable Raymond Roy II
Time Frame: 5 year
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
All ischemic and hemorrhagic stroke
Time Frame: 5 year
Determined by adverse event adjudication by the clinical events committee
In-stent stenosis
Time Frame: 5 year
Determined by the corelab adjudication of images
Parent artery patency
Time Frame: 5 year
Determined by the corelab adjudication of images
Target aneurysm retreatment
Time Frame: 5 year
Presented by the subject medical records