Pipeline for Uncoilable or Failed Aneurysms
Pipeline for Uncoilable or Failed Aneurysms
To determine the safety and effectiveness of Pipeline Embolization Device for the treatment
 of uncoilable or failed wide-necked intracranial aneurysms (IA).
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