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

• Conditions: Intracranial Aneurysms

• Registration Number: NCT05453240
• Lead Sponsor: Microvention-Terumo, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-17
• Status Verified: 2022-07
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-06
• Last Update Submitted: 2022-07-06
• Study First Posted: 2022-07-12
• Last Update Posted: 2022-07-12
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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:

  1. 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;
  2. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transient Ischemic Attack	5 year	Determined by adverse event adjudication by the clinical events committee
Cerebral vasospasm	5 year	Presented by the subject medical records
Intracranial hemorrhage including SAH and IPH	5 year	Determined by adverse event adjudication by the clinical events committee
Neurological deaths	5 year	Determined by adverse event adjudication by the clinical events committee
Complete or Stable Raymond Roy II	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	5 year	Determined by adverse event adjudication by the clinical events committee
Parent artery patency	5 year	Determined by the corelab adjudication of images
Target aneurysm retreatment	5 year	Presented by the subject medical records
In-stent stenosis	5 year	Determined by the corelab adjudication of images

Trial Locations

Locations (1)

Microvention; 🇺🇸 Aliso Viejo, California, United States