Contrast Enhanced Sonothrombolysis and Sonolysis in Stroke - a Swedish Study (CE-5S) "CE-5S"


Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

- Male or female patients ≥18 years with acute ischaemic stroke in the anterior circulation, who has given written consent for his/her participation to the study.
- Remaining neurological deficit that is ≥1 NIHSS points, sufficient to warrant treatment with tPA (not taking possible contraindications into account) and is severe enough that possible improvement is clearly analysable
- Treatment <4½ hours of symptom onset or of waking up in the morning with symptoms
- Sufficient bone window for acceptable or better acquisition of flow information with ultrasound with TIBI ≤ 4 in the symptomatic artery
- In cases with women of Childbearing Capacity (WOCBC): Only if willing to comply with effective contraception methods during the course of the trial. Acceptable methods are such as oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double-barrier methods (for example, condom and spermicide), intrauterine device (IUD), hormonal IUD

Exclusion Criteria

- Patients with premorbid modified Rankin Scale (mRS) score ≥3;
- Patients for whom a complete NIHSS cannot be obtained;
- Hemiplegic migraine with no arterial occlusion on baseline Computed Tomography of brain (CT);
- Seizure at stroke onset and no visible occlusion on baseline CT;
- Intracranial haemorrhage on baseline CT;
- Clinical presentation suggesting subarachnoid haemorrhage even if baseline CT is normal;
- Large areas of hypodense ischaemic changes on baseline CT;
- Pregnancy or breast-feeding, pericarditis; sepsis; any other serious medical illness likely to interact with treatment; confounding pre-existent neurological or psychiatric disease; unlikely to complete follow-up; any investigational drug <14 days;
- Inability to provide informed consent sufficiently clearly that the study physician can be convinced that informed consent has been given by the patient - such as severe aphasia or coma.
Specific sonothrombolysis exclusion criteria
- known hypersensitivity/allergy to SonoVue;
- recent or unstable coronary ischemia or resting angina <7 days;
- acute cardiac insufficiency, cardiac insufficiency class III/IV; serious cardiac arrhythmias;
- any right-left-shunt; severe pulmonary hypertension; uncontrolled hypertension;
- moderate to severe Chronic Obstructive Pulmonary Disease (COPD; baseline O2 saturation <80%);
- acute respiratory distress syndrome (ARDS);