HELPS Study:
HydroCoil Endovascular Aneurysm Occlusion and Packing Study
Hydrogel Embolic Coils
"These HELPS results reinforce coiling as an effective treatment for aneurysms, with an excellent technical success rate. Hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to that of bare platinum."
- Patients
499
- Countries
UK, US, France, Brazil, Germany, Australia, Argentina
- Clinical Centers
24
- Design
RCT (249 HES vs 250 BPC)
- Scope
Patients 18-75 y.o., with ruptured or unruptured aneurysms of 2-25mm, WFNS 0-3.
For AN. 2-9.9mm: Hydrogel arm targeted to have > 50% packing w/gel or > 50% gel length deployed. For AN. ≥10mm: Hydrogel arm targeted to have > 2/3 gel length deployed or >70% packing w/gel.- Purpose
Compare safety and efficacy of HydroCoil vs platinum.
Endpoints
Composite outcome: Major aneurysm recurrence (Recurrence defined as adequate space in the aneurysm to deploy further coils) + morbidity/mortality preventing angiographic f/u, at 18 months
Efficacy results
Major recurrence at 18 months: 24% HES vs 33% BPC
Primary outcome event at 18 months: 28% HES vs 36% BPC
Packing density: 63.9% HES vs 23.2% BPC
Retreatment: 3.0% HES vs 4.0% BPC including cross-over (patients who switched treatment group)
Safety results
mRS >2 at 18 Months: 15.7% HES vs 12.8% BPC
Study publications
LINK TO STUDY PAGE ISRCT Number: ISRCTN30531382
Please refer to Instruction for Use (IFU) in the specific market/country that you are looking into:
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Hydrogel Embolic Coils
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