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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02879175 -
Patients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial Aneurysms
|
||
| Completed |
NCT01139892 -
The Canadian UnRuptured Endovascular Versus Surgery Trial (CURES)
|
||
| Completed |
NCT02312856 -
Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction
|
N/A | |
| Completed |
NCT02657772 -
Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms
|
||
| Completed |
NCT01465841 -
Study of the Penumbra Coil 400 System to Treat Aneurysm
|
N/A | |
| Enrolling by invitation |
NCT05453240 -
Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device
|
||
| Completed |
NCT03550638 -
Coil System(Ton-bridgeMT) for Endovascular Embolization of Cranial Aneurysms
|
N/A | |
| Terminated |
NCT02122133 -
CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
|
||
| Completed |
NCT01541254 -
Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device
|
Phase 2/Phase 3 | |
| Terminated |
NCT01320306 -
Intracranial Aneurysms and Cognitive Function
|
||
| Recruiting |
NCT01084681 -
Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques
|
N/A | |
| Completed |
NCT00396981 -
MAPS Trial: Matrix And Platinum Science
|
Phase 4 | |
| Completed |
NCT02921711 -
TRAIL: Treatment of Intracranial Aneurysms With LVIS® System
|
||
| Recruiting |
NCT01031147 -
Contrast-free Magnetic Resonance Angiography (MRA) at 3.0 T for Intracranial Aneurysm Detection
|
N/A | |
| Recruiting |
NCT05636124 -
Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
|
N/A | |
| Completed |
NCT02921698 -
Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
|
||
| Completed |
NCT01801007 -
Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
|
N/A | |
| Terminated |
NCT01974700 -
Seizure Prophylaxis in Aneurysm Repair
|
Phase 4 | |
| Completed |
NCT01793792 -
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
|
N/A | |
| Withdrawn |
NCT01957683 -
Canadian eCLIPs™ Safety and Feasibility Study Protocol
|
Phase 1 |