Humanitarian Use Device: Neuroform Microdelivery Stent

Service: Trial Number:
054-12
Principal Investigator:
Gary R. Duckwiler
Conducted at:
Miller Children's & Women's Hospital Long Beach
Currently enrolling additional patients:
Yes
Age Range:
18 years & up

An intracranial aneurysm is a protruding bubble or sac on an artery in the brain that balloons out over time. Aneurysms have thin, weak walls and have a tendency to rupture causing hemorrhage into and around vital brain structures. Intracranial aneurysm rupture is a significant cause of subarachnoid (space between the membranes which envelop the brain) hemorrhage leading to patient morbidity and mortality. Endovascular coiling is becoming an increasingly popular treatment for cerebral aneurysms. The Neuroform Microdelivery Stent was designed as an adjunct to coil embolization of wide necked intracranial saccular aneurysms. A stent placed across the base of an aneurysm provides a scaffold for coils to prevent protrusion into the parent vessel. The FDA has designated the Neuroform Microdelivery Stent as a Humanitarian Use Device (HUD). The Neuroform Microdelivery Stent is indicated for use with GDC detachable coils for the treatment of wide necked intracranial saccular aneurysms arising from a parent vessel with a diameter greater than 2mm and less than 4.5mm that are not amenable to treatment with surgical clipping. The Neuroform Microdelivery Stent will only be used clinically for its approved indication. The data will be collected only for patient care purposes and for reporting to the IRB.

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