The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with bare platinum embolization coils.
With the stent-assisted technique to treat wide neck intracranial aneurysms, the neurovascular stent is placed across the aneurysm neck, to act as a bridge to prevent coils from protruding into the parent artery. Stenting may allow to more safely achieve a higher packing density of coils. These effects may improve the rates of complete aneurysm occlusion and enhance the durability of the coiling treatment.The LVIS™ device manufactured by MicroVention, Inc. has a braided design which may provide superior conformability and parent artery apposition, as well as a more reliable continuous and uniform neck bridging than other neurovascular stents.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Albany Medical College
Albany, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)
Imaging from each subject to be reviewed by an independent core lab who will be comparing with baseline and post procedure images.
Time frame: 6 months ± 4 weeks
Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months
A major stroke is defined as a new neurological event that persists for \>24 hours and results in a ≥ 4 point increase in the National Institutes of Health Stroke Scale (NIHSS) score compared to baseline or compared to any subsequent lower score.
Time frame: 30 days-6 months
Parent Artery Patency Measured Angiographically at 6 Months
To be assessed by Independent Core Lab.
Time frame: 6 months
Successful Delivery of the LVIS™ Device Measures by Technical Success
Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.
Time frame: 24 hours
Significant Stenosis(>50%) of the Treated Artery at 6 Months
Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.
Time frame: 6 months
Stent Migration at 6 Months
Angiographic images will be comparing post procedure sent position to 6 months
Time frame: 6 months
Device and Procedure Related Serious Adverse Events
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UT Southwestern
Dallas, Texas, United States
Methodist Hospital
Houston, Texas, United States
All Serious Adverse events will be reported per protocol
Time frame: Day 1-6months(± 4 months)
Unplanned Embolization Coiling Within 6 Months
If the target lesion(aneurysm)treated needed further embolization within 6 months of initial treatment(detected during follow up or unscheduled visit ),data will be recorded and analyzed.
Time frame: Day 1-6 months