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

This is an interventional treatment trial for Ischemic Stroke Read More

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);