Pipeline for Uncoilable or Failed Aneurysms

Patients with large or giant aneurysms of the internal carotid artery treated with PED.
Angiographic follow-up occurs at 3 and 5 years.

Inclusion Criteria:

- Age 21 to 75 years, inclusive

- Patient has a single target IA in the anterior or posterior circulation that:

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

b) Has a neck >4 mm or no discernible neck AND a size (maximum fundus diameter) >10 mm

c) Has a parent vessel with diameter 2.5 - 5.0 mm distal/proximal to the target IA

- Subject has provided written informed consent using the Institutional Review Board
(IRB)-approved consent form

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

Exclusion Criteria:

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

- Subarachnoid hemorrhage from target IA in the past 60 days

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

- 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

- Stent in place at the target IA

- Contraindication to CT scan or MRI

- 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 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)

- 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 for anterior circulation
aneurysms

- Intracranial stenosis greater than 50% in the treated vessel