Intracranial Aneurysms Clinical Trial
Official title:
NEC Trial - Nfocus - Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae - A Non-Randomized Pilot Study
The purpose of this study is to determine whether the NEC device can effectively occlude the intracranial aneurysm or the carotid/vertebrobasilar fistula and maintain parent vessel patency
SAH (subarachnoid hemorrhage) is a devastating medical emergency. As many as 60% of patients who are afflicted die in the first 30 days as a result of the SAH, or remain severely disabled from the bleed. Existing treatment options include: medical management; endovascular therapy and surgical therapy. Endovascular techniques using detachable coils have now been refined to include stents which serve to prevent the coil mass from dislodging. Further improvement is believed to be possible with the NEC which creates a seal to exclude the aneurismal lumen from blood flow without the need for coils. This study involves the endovascular placement of the NEC across the aneurysm neck in order to treat a subset of aneurysms without coils. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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