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

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

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.

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