SESAME Study:
Safety and Effectiveness of SOFIA™/SOFIA™ PLUS for Direct Aspiration in Acute Ischemic Stroke
SOFIA™ Aspiration Catheter
"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 Instruction for Use (IFU) in the specific market/country that you are looking into:
Explore more studies
STABILISE Study: Stroke: an evaluation of thrombectomy in the ageing brain version 1
SOFIA™ Aspiration Catheter & ERIC™ Stent Retriever
Request more information
The information you provide through this form is necessary to respond to your request and may be shared with the relevant Terumo Neuro group entity or entities responsible for handling it. For more information on how we process your personal data and on your rights, please refer to our privacy policy.