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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Barrow Neurological Institute
Phoenix, Arizona, United States
Rush University
Chicago, Illinois, United States
Central Du Page Hospital
Winfield, Illinois, United States
Mayo Clinic
Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.
The number of participants with occurrence of major ipsilateral stroke or neurologic death after PED placement at 180-days and the occurrence of ipsilateral stroke or neurologic death after Pipeline Embolization Devices (PED) placement at 5-years.
Time frame: 180-days and 5-years
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis.
The count of Intracranial Aneurysms (IA) evaluated as completely occluded (defined as Raymond Grade 1) without major parent artery stenosis at 180 days. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac
Time frame: 180 days
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year
The count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) (defined as Raymond-Roy grade 1) 1 year follow-up visit. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac
Time frame: 1 Year
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up
The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 3 year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac
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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)
Time frame: 3 years
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years
The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 5-year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac
Time frame: 5 years
Stenosis of the Parent Artery in PED at 3 Years
Parent artery stenosis (narrowing of the artery from which the aneurysm arises) at 3-year follow-up
Time frame: 3-years
Stenosis of the Parent Artery in PED at 5 Years
Parent artery stenosis at 5-year follow-up
Time frame: 5-years
Number of Participants With Device-Related Adverse Events at 3 Years
Number of participants with incidence of device-related adverse events at 3 year follow-up
Time frame: 3 years
Number of Participants With Device-related Adverse Events at 5 Years
Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement
Time frame: 5 years