Status:
COMPLETED
Pipeline for Uncoilable or Failed Aneurysms
Lead Sponsor:
Medtronic Neurovascular Clinical Affairs
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
To determine the safety and effectiveness of Pipeline Embolization Device for the treatment of uncoilable or failed wide-necked intracranial aneurysms (IA).
Detailed Description
Patients with large or giant aneurysms of the internal carotid artery treated with PED. Angiographic follow-up occurs at 3 and 5 years.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2014
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00777088
Start Date
October 1 2008
End Date
September 22 2014
Last Update
November 20 2018
Active Locations (10)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
Rush University
Chicago, Illinois, United States
3
Central Du Page Hospital
Winfield, Illinois, United States
4
Mayo Clinic
Rochester, Minnesota, United States