Complete Occlusion of Coilable Aneurysms

Inclusion Criteria:

- Age 21 to 75 years, inclusive

- Patient has a single target IA that:

1. is located in the following regions of the internal carotid artery: i.
Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii.
Cavernous iii. Petrous

2. is saccular

3. has a parent vessel with diameter 2.5-5.0 mm

- If target IA has a neck >4 mm, at least 2 of 3 members of an independent expert
committee (IEC) have confirmed that coil embolization with optional adjunctive
techniques** has a very high likelihood of procedural success (i.e., coil placement
and retention)

- Subject has provided written informed consent using the IRB-approved consent form

- Subject has the necessary mental capacity to participate and is willing and able to
comply with protocol requirements

- ** Adjunctive techniques include intravascular balloons ["balloon remodeling"],
3D coils, dual catheter techniques.

Exclusion Criteria:

- Target IA has BOTH neck >4 mm AND size (maximum fundus diameter) >10 mm

- More than one IA requires treatment in the next 6 months

- Subarachnoid hemorrhage in the past 60 days

- Any intracranial hemorrhage in the last 42 days

- Major surgery in the last 42 days

- Coils in place in the target IA

- Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30
days)

- Known irreversible bleeding disorder

- Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction

- Inability to tolerate, documented evidence of adverse reaction or contraindication to
study medications

- Prior stent placement at target site

- Contraindication to CT scan AND MRI

- Known allergy to contrast used in angiography that cannot be medically controlled

- Known severe allergy to platinum or cobalt/chromium alloys

- Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL)

- Woman of child-bearing potential who cannot provide a negative pregnancy test

- Evidence of active infection at the time of treatment

- Other known conditions of the heart, blood, brain or intracranial vessels that carry
a high risk of neurologic events (e.g., severe heart failure, atrial fibrillation,
known carotid stenosis)

- Current use of cocaine or other illicit substance

- Any comorbid disease or condition expected to compromise survival or ability to
complete follow-up assessments to 180 days

- Extracranial stenosis greater than 50% in the carotid artery

- Intracranial stenosis greater than 50% in the treated vessel