NCT05453240

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

Enrolling by Invitation
Not specifiedAges 18+Observational
Microvention-Terumo, Inc.
~250 participants
Updated 2025-06-17 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete or Stable Raymond Roy II
Measured over 5 year
+8 more outcomes measured
Intracranial Aneurysms
1 sites across 1 states
California1

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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.
Availability of Medical Health Records;
Subject whose age is ≥ 18;
Appropriate or Waived Consent:

Exclusion

Subjects not treated according to the currently approved indications for use
  • Complete or Stable Raymond Roy II5 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

  • Intracranial hemorrhage including SAH and IPH5 year

    Determined by adverse event adjudication by the clinical events committee

  • All ischemic and hemorrhagic stroke5 year

    Determined by adverse event adjudication by the clinical events committee

  • Neurological deaths5 year

    Determined by adverse event adjudication by the clinical events committee

  • Transient Ischemic Attack5 year

    Determined by adverse event adjudication by the clinical events committee

  • Parent artery patency5 year

    Determined by the corelab adjudication of images

  • In-stent stenosis5 year

    Determined by the corelab adjudication of images

  • Target aneurysm retreatment5 year

    Presented by the subject medical records

  • Cerebral vasospasm5 year

    Presented by the subject medical records