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

NCT05453240 | Enrolling By Invitation

• 1 other identifier: CL11008
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysms

Outcome Measures

Primary Outcomes (9)

• 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

  5 year

• Intracranial hemorrhage including SAH and IPH

  Determined by adverse event adjudication by the clinical events committee

  5 year

• All ischemic and hemorrhagic stroke

  Determined by adverse event adjudication by the clinical events committee

  5 year

• Neurological deaths

  Determined by adverse event adjudication by the clinical events committee

  5 year

• Transient Ischemic Attack

  Determined by adverse event adjudication by the clinical events committee

  5 year

• Parent artery patency

  Determined by the corelab adjudication of images

  5 year

• In-stent stenosis

  Determined by the corelab adjudication of images

  5 year

• Target aneurysm retreatment

  Presented by the subject medical records

  5 year

• Cerebral vasospasm

  Presented by the subject medical records

  5 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population conforms to currently approved Indications for Use: Subjects with wide-necked (neck ≥ 4 mm or dome to neck ratio \< 2) intracranial, saccular aneurysms arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4.5 mm who underwent treatment with LVIS device since approval in the local geography of researched sizes.

You may qualify if:

• 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;.

You may not qualify if:

• Subjects not treated according to the currently approved indications for use

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

Study Sites (1)

Microvention

Aliso Viejo, California, 92656, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 12, 2022
• Study Start: November 17, 2020
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

US (1)