Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)

MicroVention

Status: Completed

Conditions: Intracranial Aneurysms

Treatments: Device: LVIS™ and LVIS™ Jr

Study type: Interventional

Funder types: Industry

Identifiers

NCT01793792

G110188/S004 (Other Identifier)

CL11002

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.

Enrollment: 153 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject age between 18 and 75 years
• Subject with an unruptured or ruptured(>30days since occurence), wide-necked (neck ≥4mm or dome to neck ratio <2)intracranial saccular aneurysm (<20mm maximum diameter in any plane)

Exclusion criteria

• Subject with significant extra or intracranial stenosis of the parent artery (>50%) proximal to the target aneurysm.
• Subject with any condition which in the opinion of the treating physician would place the subject at high risk of embolic stroke
• Subject with contraindications to the use of antiplatelet agents
• Subject who is unable to complete the required follow-up

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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153 participants in 1 patient group

Device: LVIS

Other group

Description:

The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms. Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device

Treatment:

Device: LVIS™ and LVIS™ Jr