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

Intracranial Aneurysms Clinical Trial

— LVIS PAS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05453240
• Other study ID #: CL11008
• Status: Enrolling by invitation
• Start date: November 17, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: July 2022
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Locations

Country	Name	City	State
United States	Microvention	Aliso Viejo	California

Sponsors (1)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Intracranial hemorrhage including SAH and IPH	Determined by adverse event adjudication by the clinical events committee	5 year
Primary	All ischemic and hemorrhagic stroke	Determined by adverse event adjudication by the clinical events committee	5 year
Primary	Neurological deaths	Determined by adverse event adjudication by the clinical events committee	5 year
Primary	Transient Ischemic Attack	Determined by adverse event adjudication by the clinical events committee	5 year
Primary	Parent artery patency	Determined by the corelab adjudication of images	5 year
Primary	In-stent stenosis	Determined by the corelab adjudication of images	5 year
Primary	Target aneurysm retreatment	Presented by the subject medical records	5 year
Primary	Cerebral vasospasm	Presented by the subject medical records	5 year