Safety and Effectiveness of SOFIA™/SOFIA™ PLUS when used for direct aspiration as a first line treatment technique in patients suffering an Acute Ischemic Stroke in the anterior circulation

Study Objective:

To demonstrate that use of SOFIA™/SOFIA™ PLUS catheter for direct aspiration as a first line treatment technique is fast, safe and effective in patients suffering an Acute Ischemic Stroke when assessed at 24 hours, discharge and 90 days after treatment.

Participation conditions

Inclusion criteria:

1. Participant ≥ 18 years
2. Demonstrated occlusion of the distal intracranial carotid artery, middle cerebral artery (M1 or M2) or anterior cerebral artery (A1 or A2) proven by CT and/or MRI
3. NIHSS ≥ 2 and <30 at screening
4. Start of the thrombectomy procedure within 6 hours of the onset of stroke symptoms
5. Pre event mRS ≤1
6. Patient or patient’s legally authorized representative or impartial witness/independent physician has received information about data collection and has signed and dated an Informed Consent Form

Exclusion criteria

1. Patient is more than 6 hours from symptom onset
2. Evidence of cerebral ischemia in the posterior circulation
3. Rapidly improving neurologic examination
4. Severe unilateral or bilateral carotid artery stenosis requiring stent treatment
5. Presence of an existing or pre-existing large territory infarction
6. Absent femoral pulses
7. Excessive vascular tortuosity that will likely result in unstable access
8. Pregnancy; if a woman is of child-bearing potential and urine or serum beta HCG test is positive
9. Known contrast product allergy
10. Patient has a severe or fatal comorbidity that will likely prevent improvement or follow up or that will render the procedure unlikely to benefit the patient
11. Evidence of intracranial hemorrhage (SAH, ICH, etc.)
12. Imaging exclusion criteria:
• Significant mass effect with midline shift or intracranial tumor
• Baseline non-contrast CT or DWI MRI evidence of a moderate/large core defined as extensive early ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) 0-5

Hospital East Limburg (Belgium)