Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Phase 1

Terminated

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT00507806
• Lead Sponsor: ImaRx Therapeutics

Brief Summary

The study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere \[Definity®\]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study Completion: 2006-05
• Status Verified: 2007-07
• Study First Submitted: 2007-07-25
• Study First Submitted QC: 2007-07-25
• Last Update Submitted: 2007-07-25
• Study First Posted: 2007-07-27
• Last Update Posted: 2007-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Measurable focal neurological deficit (National Institutes of Health Stroke Scale [NIHSS] score > 4 points)
• tPA eligible
• Occlusion of the middle cerebral artery

Exclusion Criteria

• Right to left cardiac shunt
• Uncontrolled hypertension
• Absent temporal windows

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of symptomatic intracranial hemorrhage	72 hours

Secondary Outcome Measures

Name	Time	Method
Complete recanalization of the occluded artery (TIBI 4-5)	End of treatment
NIHSS score of 0-2	24 hours
Favorable outcome (modified Rankin Scale or NIHSS 0-1)	3 months