Aneurysm Study of Pipeline in an Observational Registry (ASPIRE)
The primary objective of this study is to further expand the body of clinical knowledge in patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial aneurysms (IAs or ICAs) according to Pipeline's labeled indication.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Aneurysm Study of Pipeline in an Observational Registry|
- Incidence of Neurological Adverse Events following PED use [ Time Frame: From Device placement until last follow up, for an average of 3 years of follow up for each subject enrolled ] [ Designated as safety issue: Yes ]
The primary endpoint will consist of a composite of any/all of the events listed below.
- Incidence of spontaneous rupture of Pipeline treated aneurysm
- Incidence of other (non-aneurysmal) intracranial hemorrhage, ipsilateral and contralateral
- Incidence of ischemic stroke
- Incidence of symptomatic and asymptomatic parent artery stenosis
- Incidence of permanent cranial neuropathy
- Incidence of change in baseline neurologic signs/symptoms related to Pipeline treated ICA(s) at last assessment
|Study Start Date:||May 2012|
Aneurysms treated with Pipleline
Aneurysms treated with Pipleline. All patients independently treated according to the labeled indications for use with the Pipeline Embolization Device
Device: Pipeline Embolization Device
Aneurysms treated independent of study entry with the Pipeline Embolization Device. This is an observational, non-interventional study.
Other Name: PED
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557036
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