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

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 AFIB (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