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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05453240
Other study ID # CL11008
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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