GEL THE NEC Study:
Registry for Study of Coils in Intracranial Aneurysms
Hydrogel Embolic Coils
"Endovascular treatment of intracranial aneurysms with HydroSoft coils resulted in complete/near complete occlusion rates of 88% and a major complication rate of 1.8%."
- Patients
599
- Countries
US, UK, China, Korea & Japan
- Clinical Centers
27
- Design
Single arm prospective
- Scope
Patients 21 – 90 y.o. with a ruptured or unruptured aneurysm, 3-15mm, H&H<4.
- Purpose
Assess safety and efficacy of treating aneurysms with Hydrosoft coils used as finishing coils.
Endpoints
Recanalization or recurrence rates at 6 – 18 months post coiling (assessed by Corelab)
Efficacy results
Successful deployment of HydroSoft coils: 96.4%
Complete occlusion rate at 9 months: 63.2%
Adequate occlusion rate at 9 months: 88.4%
Recanalization: 10.8%
Retreatment: 3.4%
Safety results
Procedure-related mortality: 0.5%
Procedure-related major morbidity: 1.3%
LINK TO STUDY PAGE CinicalTrials.gov ID NCT01000675
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Hydrogel Embolic Coils
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