NCT00243906

Interventional Management of Stroke (IMS) II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the effects of delivering intra-arterial recombinant tissue plasminogen activator (rt-PA) and ultrasound to the site of the blood clot blocking blood flow to the brain of stroke patients.

Detailed description

The overall goal of Interventional Management of Stroke (IMS II) study is to refine thrombolytic therapy for patients with acute ischemic stroke who can be treated within three hours of stroke onset. This multi-center, non-randomized pilot study will provide preliminary data about the benefits and risks of combined intravenous (IV) and intra-arterial (IA) recombinant tissue plasminogen activator (rtPA) and low-intensity ultrasound energy in ischemic stroke patients with baseline NIHSSS \>/= 10 in whom intravenous treatment can be started within three hours of stroke onset. rt-PA is a thrombolytic, clot-dissolving drug. The primary objectives for the study are to obtain reliable estimates of the effectiveness and safety of a treatment approach combining IV/IA rt-PA and ultrasound for stroke patients; and to determine if the estimated effectiveness of combined IV/IA rt-PA at 3 months-as compared to the 3 month outcome of placebo-treated patients in the NINDS rt-PA Stroke Trial-warrants proceeding to a large, phase III randomized trial.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	Recombinant tissue plasminogen activator	Low-dose IV rt-PA (0.6 mg/kg) followed by delivery of additional IA rt-PA (up to 22 mg).
PROCEDURE	Low-intensity ultrasound	Delivery of additional IA rt-PA (up to 22 mg) in the setting of low-energy ultrasound via the EKOS microinfusion catheter at the site of IA occlusion in acute ischemic stroke patients with large strokes (NIHSS \>/= 10) treated within 3 hours of symptoms onset.

Timeline

• Start date: 2003-01-01
• Primary completion: 2006-05-01
• Completion: 2007-05-01
• First posted: 2005-10-25
• Last updated: 2012-07-25

Locations

1 site across 1 country: United States