SOFIA™ Aspiration Catheter
STABILISE: Stroke: an evaluation of thrombectomy in the ageing brain version 1
"Study indicated feasibility of a phase II RCT trial approach for assessing new thrombectomy devices. In a broad LAO stroke population ERIC and SOFIA were not statistically different from control devices. Larger trials are needed."
- Patients
66
- Country
UK
- Clinical Centers
4
- Design
RCT (45 ERIC/SOFIA vs 21 control)
- Scope
Patients ≥ 18 y.o. with LVO stroke treatable within 5.5hrs (8.5hrs for posterior circulation), of symptom onset, NIHSS≥ 6, treatable by ERIC/SOFIA or other standard CE approved mechanical thrombectomy devices.
- Purpose
Assessment of trial feasibility and technical efficacy and safety of use of ERIC and/or SOFIA to treat large vessel occlusion.
Endpoints
Primary: mTICI ≥2b-3 (Corelab assessed)
Secondary: mRS at 90 days and 365 days (independence and shift), mortality at 30 days, sICH, procedural complications
Efficacy results
mTICI 2b-3: 72% ERIC/SOFIA vs 86% Control
Safety results
Procedural complications: 9% ERIC/SOFIA vs 14% Control
Symptomatic ICH: 0% ERIC/SOFIA vs 5% Control
30-day mortality: 9% ERIC/SOFIA vs 14% Control
mRS 0-2 at 90 days: 40% ERIC/SOFIA vs 43% Control
mRS 0-2 at 365 days: 66% ERIC/SOFIA vs 62% Control
LINK TO STUDY PAGE ISRCTN Number: ISRCTN15698516
SPONSOR: Newcastle Clinical Trials Unit (UK)
Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.
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