Interventional Management of Stroke Study "IMS - II"

Completed

Phase N/A Results

Trial Description

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.

Interventions

Trial Design

Pilot, non-randomized, safety and feasibility study.

Patient Involvement

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.

Outcomes

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.

Sponsors

National Institute for Neurological Disorders and Stroke, NIH, EKOS Corporation