Pipeline for Uncoilable or Failed Aneurysms

Completed · Not applicable

Conditions studied: Intracranial Aneurysm

In brief

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

Key facts

Study ID

NCT00777088

Run by

Medtronic Neurovascular Clinical Affairs

People needed

108

Starts

2008-10-01

Expected to finish

2014-09-22

Last updated by the study team

2018-11-20

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• Rush University — Chicago, Illinois, United States
• Central Du Page Hospital — Winfield, Illinois, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University St. Louis — St Louis, Missouri, United States
• University of Buffalo — Buffalo, New York, United States
• New York University — New York, New York, United States
• Stony Brook University — Stony Brook, New York, United States
• National Institute of Neurosurgery — Budapest, Hungary
• Hacettepe University — Ankara, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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