SOFIA™ Aspiration Catheter
SOFAST: SOFIA Aspiration System as first-line Technique
"First-line aspiration with SOFIA 6F is safe and effective with high revascularization rates and short procedure times."
- Patients
108
- Country
US
- Clinical Centers
12
- Design
Single arm prospective
- Scope
Patients 21-85 y.o. presenting with an acute ischemic stroke from imaging-confrimed LVO in the anterior cerebral circulation within 90min from arteriotomy, Aspect ≥ 6 and NIHSS ≥ 5, within 8 hrs of symptom onset or last known well. Those eligible to be treated with SOFIA™ Flow Plus 6F as 1st line treatment.
- Purpose
To assess safety and efficacy of SOFIA Flow Plus 6F used for first-line aspiration in anterior circulation LVO stroke patients.
Endpoints
Proportion of patients with vascular recanalization defined as mTICI≥2b at the end of the procedure per Core Lab evaluation
Efficacy results
At the end of procedure:
mTICI≥2b= 97.2%
mTICI≥2c= 85.2%
mTICI 3=55.6%
With SOFIA 6F 1st line aspiration:
mTICI≥2b= 87.0%
mTICI≥2c= 79.6%
mTICI 3= 52.8%
FPE (TICI3)= 50.9%
FPE (mTICI≥2b)= 75.0%
Median times:
From arteriotomy to clot contact: 12 min
From arteriotomy to mTICI≥2b: 17 min
Safety results
Symptomatic within 24 hours = 0.9%
Vessel perforation = 0.9%
ENTs = 0%
At 3 months:
all cause mortality = 7.4%
At 3 months:
mRS 0-2 = 66.7%
Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.
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