NCT00507806TerminatedPhase 1
Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke
ImaRx Therapeutics0 sitesStarted: March 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Primary Endpoint
- Incidence of symptomatic intracranial hemorrhage
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Incidence of symptomatic intracranial hemorrhage
Time Frame: 72 hours
Secondary Outcomes
- 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)
Investigators
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