To provide preliminary data concerning the risks and benefits of combined intravenous and intra-arterial (IV/IA) rt-PA plus low-energy ultrasound in patients with ischemic stroke.
- Tissue plasminogen activator (Activase®)Drug
Intervention Desc: Thrombolytic
Pilot, non-randomized, safety and feasibility study.
Patients will receive 0.6 mg/kg of IV t-PA (alteplase) over one half hour (15% as a bolus) followed as soon as possible by a cerebral angiogram. If a thrombus is identified, the tip of the catheter will be positioned into the proximal portion of the clot. Intra-arterial delivery of t-PA will begin with a bolus of 2 mg, and then 10 mg/hr for two hours, which allows for the same 22 mg maximum dose by IA.
|Type||Measure||Time Frame||Safety Issue|
|Primary||The primary safety outcome measures are mortality, symptomatic ICH and life-threatening bleeding. The primary measure of efficacy is the modified Rankin Score (favorable outcome defined as 0-1). The primary angiographic outcome measure is the rate of TIMI Grade 3 recanalization of the targeted occluded vessel.|