Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Intracranial Aneurysms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS® Device
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.
Primary outcome measures
- Complete or Stable Raymond Roy II [Time frame: 5 year]
- Intracranial hemorrhage including SAH and IPH [Time frame: 5 year]
- All ischemic and hemorrhagic stroke [Time frame: 5 year]
- Neurological deaths [Time frame: 5 year]
- Transient Ischemic Attack [Time frame: 5 year]
- Parent artery patency [Time frame: 5 year]
- In-stent stenosis [Time frame: 5 year]
- Target aneurysm retreatment [Time frame: 5 year]
- Cerebral vasospasm [Time frame: 5 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Microvention — Aliso Viejo
Identifiers
NCT: NCT05453240 · CL11008