Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Feasibility Study of the MicroVention,Inc.(LVIS™) Neurovascular Self-Expanding Retrievable Stent System in the Treatment of Wide-Necked Intracranial Artery Aneurysms

Conditions
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Intracranial Aneurysms

Intervention / Treatment
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* Device: Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject whose age is between 18 and 80 years old Subject with unruptured wide neck, saccular,intracranial aneurysm, < 20mm maximum diameter in any plane ( wide neck defined as neck width ≥ 4mm or dome to-neck ratio < 2). Subject's aneurysm arises from a parent vessel with a diameter of ≥ 2.5m and ≤ 4.5mm. Subject or his/her legally authorized representative understands the nature of the procedure and provides signed informed consent form. Subject is willing to return to the investigational site for the 30- day and 6-month follow-up evaluations Exclusion Criteria: Subject who presents with ruptured aneurysm, unless rupture occured 30 days or more prior to screening. Subject who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region. Subject with an International Normalized Ratio (INR)≥ 1.5 Subject with serum creatinine level >2mg/dl at time of enrollment Subject with known allergies to nickel-titanium metal Subject with known allergies to aspirin, heparin, ticlopidine, or clopidogrel Subject with a life threatening allergy to contrast(unless treatment for allergy is tolerated) Subject who has a known cardiac disorder, likely to be associated with cardioembolic symptoms such as atrial fibrillation Subject with any condition which in the opinion of the treating physician would place the subject at a high risk of embolic stroke Subject who is currently participating in another clinical research study Subject who has had a previous intracranial stenting procedure associated with the target aneurysm Subject who is unable to complete the required follow-up Subject who is pregnant or breastfeeding Subject who has participated in a drug study within the last 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) | Device: Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)<br>* Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)<br>* Other names: Low-profile Vizualized Intraluminal Support Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 30 days-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Artery Patency Measured Angiographically at 6 Months | To be assessed by Independent Core Lab. | 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. | 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. | 6 months | 
| Stent Migration at 6 Months | Angiographic images will be comparing post procedure sent position to 6 months | 6 months | 
| Device and Procedure Related Serious Adverse Events | All Serious Adverse events will be reported per protocol | 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. | Day 1-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracranial aneurysm, wide-neck, saccular, endovascular treatment, coil embolization, stent, bare platinum