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

M

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)

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

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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