SOFIA™ Aspiration Catheter
SESAME: Safety and Effectiveness of SOFIA™/SOFIA™ PLUS for Direct Aspiration in Acute Ischemic Stroke
"Primary aspiration with the SOFIA/SOFIA PLUS catheter demonstrates favorable safety and efficacy profiles in the treatment of anterior circulation LVO. These findings support the utilization of this technique as a first-line approach in mechanical thrombectomy for AIS, contributing to the growing body of evidence endorsing the effectiveness of direct aspiration thrombectomy in stroke management."
- Patients
246
- Countries
France, Germany, Austria, Italy, Netherlands
- Clinical Centers
15
- Design
Single arm prospective
- Scope
Patients ≥ 18 y.o. presenting with an acute stroke in the anterior cerebral circulation, NIHSS of 2-30, pre stroke mRS<2, ASPECTS>5 that can be treated within 6 hrs from symptom onset.
- Purpose
To demonstrate that use of SOFIA/SOFIA PLUS catheter for direct aspiration as a first line treatment technique is fast, safe and effective up to 90 days.
Endpoints
Efficacy:
Successful recanalization (mTICI 2b-3)
FPE (mTICI 2C-3) assessed by Corelab
Safety:
Proportion of patients with a good clinical outcome, defined as mRS ≤ 2 at 90 days post-treatment, as assessed by an independent certified neurologist
Efficacy results
After 1st line aspiration:
mTICI ≥2b: 72.8%
mTICI ≥2c: 57.3%
mTICI 3: 34.1%
FPE (mTICI 2c-3): 48.8%
Safety results
Symptomatic ICH: 4.4%
ENT: 3.7%
Mortality: 24.4%
mRS 0-2 at 90 days: 63.8%
LINK TO STUDY PAGE ClinicalTrials.gov ID NCT03417349
SPONSOR: Heidelberg Hospital
Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.
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