Evaluation of the SONAS® Ultrasound Device for the Assessment of Bilateral Cerebral Perfusion in Subjects With Acute Stroke

Inclusion Criteria:

1. Written informed consent obtained

2. Male or female subject ≥18 years

3. Clinical diagnosis of acute stroke (NIHSS score: ≥10)

4. Time of stroke symptoms onset: ≤24 hours

5. Confirmed occlusion of either the proximal middle cerebral artery (occlusion of theproximal, middle or distal M1-segment) or the distal internal carotid artery (including carotid-T occlusion) by cMRI or cCT (including perfusion weighted imagingsequences)

6. Women of childbearing potential must have a negative urine or serum beta humanchorionic gonadotropin result, obtained within 24 hours before administration ofSonoVue®

7. Women of non-childbearing potential can be included in the clinical investigation, ifconfirmed by fulfilling at least 1 of the following criteria:

• Postmenopausal (age-related amenorrhea for ≥12 consecutive months)

• Documentation (based on medical records, medical examination, or medical historyinterview) of irreversible surgical sterilization by bilateral oophorectomy,bilateral salpingectomy, or hysterectomy

Exclusion Criteria:

1. Subjects with known contraindications to the use of SonoVue®:

• Subjects known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, andsubjects with acute respiratory distress syndrome

• SonoVue® must not be used in combination with dobutamine in subjects withconditions suggesting cardiovascular instability where dobutamine iscontraindicated

• Known hypersensitivity to any of the following substances:

• Sulphur hexafluoride

• Macrogol 4000

• Distearoylphosphatidylcholine

• Dipalmitoylphosphatidylglycerol sodium

• Palmitic acid

2. Pregnant women

3. Subjects with severe cardiac or pulmonary disease as defined by the treating physician

4. Subjects with acute endocarditis and/or artificial heart valve

5. Subjects with acute systemic inflammation and/or sepsis

6. Subjects with hyperactive coagulation states and/or a recent thromboembolism

7. Subjects with end stage renal or hepatic disease

8. Subjects with known metal skull implants in the anatomical area of thetemporal/parietal bones, or with anatomical formation of the head or ear that mayinterfere with proper headset placement, or with significant observable asymmetry inhead formation

9. Subjects with known implanted deep brain stimulation devices

10. Subjects with known or suspected fracture(s) of the temporal/parietal skull bones, orwith open skin injuries in the anatomical area of the temporal/parietal lobes

11. Subjects with known significant blood loss prior to or during the test procedure,SONAS® should not be used unless the blood pressure of the subject is verified to bestabilized

12. Subjects with axial (coronal) skull diameters of <12 cm or >18 cm

13. Subjects participating in another clinical investigation with an investigational drugor device within 3 months of enrollment or planned participation at any time duringthis clinical investigation

14. Previous participation in this clinical investigation

15. Employees of the clinical investigation site or the sponsor directly involved with theconduct of the clinical investigation, or immediate family members of any suchindividuals

16. Subjects committed to an institution by an order issued either by the courts or by anauthority