Ultrasound Enhanced Thrombolytic Therapy of Middle Cerebral Artery Occlusion


Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

- acute ischemic stroke in the MCA territory according to clinical and cranial computed tomography (CT) or cranial MR imaging (MRI) findings
- patient undergoing iv thrombolysis with t-PA within 3 hours after stroke onset
- Occlusion of sphenoidal (M1) or insular (M2) segment of the MCA at CT (CTA), MR (MRA) or catheter (CA) angiography
- appropriate temporal bony window without echocontrast agents for insonation with TCCS
- full functional independence prior to present stroke (mRS 0-1), use of a cane for walking due to comorbid condition is acceptable
- written informed consent, signed and dated by the subject (or subject's authorized representative, if allowed by local laws) and by the person obtaining the consent, indicating agreement to comply with all protocol-specific procedures

Exclusion Criteria

- unconsciousness (more than 2 points on item 1a on NIHSS)
- history of intracranial hemorrhage, arteriovenous malformation or aneurysm
- severe cranio-cerebral trauma within the last 3 months
- symptoms of subarachnoidal hemorrhage
- time of symptom onset unclear
- large surgical intervention or trauma within the last 10 days
- expected survival below 90 days after iv t-PA treatment
- severe hepatic disease, esophageal varices, acute pancreatitis
- septic embolism, endocarditis, pericarditis after myocardial infarction
- pregnancy or childbirth within the last 30 days or nursing mothers
- history of hemorrhagic diathesis or coagulopathy
- untreatable increase of arterial blood pressure (>185mmHg systolic, >110mmHg diastolic)
- intracranial hemorrhage, arteriovenous malformations or aneurysm at brain imaging
- thrombocytes <100'000 per microliter
- international normalized ratio (INR)>1.7 or partial thromboplastin time (PTT) prolongated
- serum glucose <2.7mmol/l or >22.2mmol/l
- severe renal insufficiency or other contraindications against CT-contrast agents