HES Coils

GEL THE NEC: Registry for Study of Coils in Intracranial Aneurysms

"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


Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.

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