Status:
COMPLETED
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
Lead Sponsor:
Microvention-Terumo, Inc.
Conditions:
Intracranial Aneurysms
Eligibility:
All Genders
18-75 years
Phase:
NA
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 endovasc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT01793792
Start Date
July 1 2013
End Date
January 1 2016
Last Update
June 22 2025
Active Locations (21)
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1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
2
Dignity Health/Mercy San Juan Medical Center
Carmichael, California, United States, 95608
3
Colorado Neurological Institute
Englewood, Colorado, United States, 80113
4
Rush University Medical Center
Chicago, Illinois, United States, 60612