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

Post-Approval Study - 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Intracranial Aneurysms

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• United States
  • California
    • Aliso Viejo, California, United States, 92656
      • Microvention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Microvention-Terumo, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CL11008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No