RAGE Study:
Ruptured Aneurysms treated with HydroGEl Coils
Hydrogel Embolic Coils
RAGE study demonstrates that "HES coils are safe and effective for the management of ruptured intracranial aneurysms, achieving a superior rate of adequate occlusion when compared with a literature-based performance goal for bare platinum coils. Rates of target aneurysm rebleeding after HES coil embolization were very low."
- Patients
771
- Countries
US & Canada
- Clinical Centers
45
- Design
Prospective, single arm, multicenter post-market study
- Scope
Patients 18-80 y.o. with ruptured, untreated saccular intracranial aneurysms, 2-15mm in diameter, H&H of III or less.
- Purpose
To determine occlusion rates and safety when hydrogel coils are used in the treatment of ruptured intracranial aneurysms.
Endpoints
Safety: Procedure or disease related death within 30 days; major stroke within 30 days; and major ipsilateral stroke, neurological death, or aneurysm rebleeding within 18 months of treatment.
Effectiveness: Adequate angiographic occlusion at 18 ± 6 months (assessed by core lab using DSA) without interim retreatment secondary to aneurysm recurrence or rebleed of the target aneurysm.
Efficacy results
At 18±6 months:
Successful primary efficacy outcome: 75.0%
Adequate occlusion: 86.0%, superior to the prespecified performance goal of 80.4% (p=0.0004)
Retreatment due to aneurysm recurrence: 13.2%
Safety results
Primary Safety endpoint events in 7.6% of subjects.
Within 30 days:
Re-bleeding rate: 0.3%
Procedure or disease related death: 2.6%
Major stroke: 4.2%
At 18 months:
Re-bleeding rate: 0.5%
Neurological death: 2.8%
Major ipsilateral stroke: 2.5%
Favorable outcomes (mRS 0–2): 87.5%
LINK TO STUDY PAGE: NCT03252314
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MM2356 WW 09/26
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