NCT01054391

Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae

NEC Trial - Nfocus - Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae - A Non-Randomized Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Nfocus Neuromedical · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Intracranial Aneurysms
• Cavernous Carotid Fistula
• Vertebrobasilar Fistula

Interventions

Type	Name	Description
DEVICE	NEC - Neurovascular Embolization Cover	Implantation of NEC for the treatment of intracranial aneurysms and carotid/vertebrobasilar fistuale arising from a parent vessel of 2.5 to 4.5mm

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-12-01
• First posted: 2010-01-22
• Last updated: 2010-01-22

Locations

2 sites across 1 country: Germany