Combined Lysis of Thrombus in Brain ischemia with Transcranial Ultrasound and Systemic TPA [SPOTRIAS] "CLOTBUST Phase I"

Completed

Phase N/A Results

Trial Description

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).

Interventions

Trial Design

Non-randomized, non-controlled, prospective Phase I trial.

Patient Involvement

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.

Outcomes

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.