Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS

Microvention-Terumo, Inc.21 sites in 1 country153 target enrollmentJuly 1, 2013

ConditionsIntracranial Aneurysms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intracranial Aneurysms
Sponsor: Microvention-Terumo, Inc.
Enrollment: 153
Locations: 21
Primary Endpoint: Primary Effectiveness Composite Success "Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment"
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2013

End Date

January 1, 2016

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Microvention-Terumo, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Primary Effectiveness Composite Success "Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment"

Time Frame: 12 months

Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months

Time Frame: 12 months