Last updated on January 2015

Prospective study on Embolization of Intracranial Aneurysms with Pipeline™ Embolization Device Premier NV-PED-07


Brief description of study

Prospective study on Embolization of Intracranial Aneurysms with Pipeline™ Embolization Device Premier NV-PED-07

Detailed Study Description

The Pipeline™ device has been commercialized in the US since 2011 for the endovascular treatment of adults with large (≥ 10 - 24 mm) or giant (≥ 25 mm) wide-necked IAs in the ICA from the petrous to the superior hypophyseal segments. Over this period of time, additional long-term data has been generated which further confirms the safety and effectiveness of the Pipeline™ device for this indication. Of particular note, long-term data from the PUFs study demonstrate a 0% recurrence rate of occluded aneurysms up to 3-years post-procedure. 67 Additionally, in much geography outside the US, the Pipeline™ device has been approved and commercialized since 2008 for endovascular embolization of cerebral aneurysms.

Although alternative treatment options (surgical clipping or stent-assisted coiling) exist for some small and medium, wide-necked IAs, there remains a need for more effective and durable longterm IA treatments. To that end, the present study aims to evaluate the safety and effectiveness of the Pipeline™ device in unruptured, wide-necked IAs measuring ≤ 12 mm (small and medium sized) located in the ICA up to the terminus and the vertebral artery (VA) segment up to and including the posterior inferior cerebellar artery (PICA).

Clinical Study Identifier: TX140015

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Sara Renfrow

Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
Lexington, KY USA
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