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NCT00507806 Clinical Trial

Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:
Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00507806
Other study ID # MRX-815-401
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received July 25, 2007
Last updated July 25, 2007
Start date March 2005
Est. completion date May 2006

Study information
Verified date July 2007
Source ImaRx Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• perflutren lipid microsphere

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
ImaRx Therapeutics

References & Publications (1)

Alexandrov AV, Molina CA, Grotta JC, Garami Z, Ford SR, Alvarez-Sabin J, Montaner J, Saqqur M, Demchuk AM, Moyé LA, Hill MD, Wojner AW; CLOTBUST Investigators. Ultrasound-enhanced systemic thrombolysis for acute ischemic stroke. N Engl J Med. 2004 Nov 18;351(21):2170-8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of symptomatic intracranial hemorrhage 72 hours
Secondary Complete recanalization of the occluded artery (TIBI 4-5) End of treatment
Secondary NIHSS score of 0-2 24 hours
Secondary Favorable outcome (modified Rankin Scale or NIHSS 0-1) 3 months
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