To determine the rates of arterial recanalization and the recovery outcomes in patients with acute ischemic stroke who were treated with transcranial ultrasound in conjunction with tissue plasminogen activator (tPA).
- Tissue plasminogen activator (Activase®)Drug
Intervention Desc: Thrombolytic
Non-randomized, non-controlled, prospective Phase I trial.
Patients were infused with tPA 0.9 mg/kg while being treated with 2 MHz transcranial ultrasound. Residual flow was monitored by transcranial Doppler (TCD), and patients' recoveries were evaluated by physicians unaware of the TCD results.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Complete arterial recanalization (defined as a Thrombolysis in Brain Ischemia (TIBI) grade of 4 - 5), dramatic recovery (defined as a National Institute of Heath Stroke Scale (NIHSS) score of < 3), or early recovery (defined as a NIHSS score reduction by > 10 points) at 2 - 24 hours post-treatment; incidence of symptomatic intracerebral hemorrhage (ICH) at 72 hours post-stroke.|