Clinical trial NCT03290053 (phase 3, status: terminated)
Conditions: ischemic stroke
ICD codes: I25.5, H47.013, H93.013, G45.9, H47.011, H47.012, H47.019
Drugs: sonovue, sodium chloride
SMILES: FS(F)(F)(F)(F)F, [Na+].[Cl-]
Reason stopped: 
    poor inclusion rate & lack of funding
  
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);