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Enrolling by Invitation

NCT Number: NCT05453240

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

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.

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Key information

Conditions

Intracranial Aneurysms Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Microvention

Aliso Viejo, California, 92656, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Intracranial hemorrhage including SAH and IPH

    Time frame: 5 year

    Determined by adverse event adjudication by the clinical events committee

  3. All ischemic and hemorrhagic stroke

    Time frame: 5 year

    Determined by adverse event adjudication by the clinical events committee

  4. Neurological deaths

    Time frame: 5 year

    Determined by adverse event adjudication by the clinical events committee

  5. Transient Ischemic Attack

    Time frame: 5 year

    Determined by adverse event adjudication by the clinical events committee

  6. Parent artery patency

    Time frame: 5 year

    Determined by the corelab adjudication of images

  7. In-stent stenosis

    Time frame: 5 year

    Determined by the corelab adjudication of images

  8. Target aneurysm retreatment

    Time frame: 5 year

    Presented by the subject medical records

  9. Cerebral vasospasm

    Time frame: 5 year

    Presented by the subject medical records

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Registry information

Official study title

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

Acronym: LVIS PAS

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jul 12, 2022
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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