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Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

This study has been terminated.
(for administrative reasons)
Information provided by:
ImaRx Therapeutics Identifier:
First received: July 25, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
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.

Condition Intervention Phase
Acute Ischemic Stroke Drug: perflutren lipid microsphere Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Resource links provided by NLM:

Further study details as provided by ImaRx Therapeutics:

Primary Outcome Measures:
  • Incidence of symptomatic intracranial hemorrhage [ Time Frame: 72 hours ]

Secondary Outcome Measures:
  • Complete recanalization of the occluded artery (TIBI 4-5) [ Time Frame: End of treatment ]
  • NIHSS score of 0-2 [ Time Frame: 24 hours ]
  • Favorable outcome (modified Rankin Scale or NIHSS 0-1) [ Time Frame: 3 months ]

Study Start Date: March 2005
Study Completion Date: May 2006
Intervention Details:
    Drug: perflutren lipid microsphere
    Other Name: Definity

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00507806

Sponsors and Collaborators
ImaRx Therapeutics
Principal Investigator: Andrei Alexandrov, MD The University of Texas Health Science Center, Houston
  More Information

Publications: Identifier: NCT00507806     History of Changes
Other Study ID Numbers: MRX-815-401
Study First Received: July 25, 2007
Last Updated: July 25, 2007

Keywords provided by ImaRx Therapeutics:
Acute Ischemic Stroke
Transcranial Doppler ultrasound
Symptomatic Intracranial Hemorrhage
modified Rankin Scale

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia processed this record on August 18, 2017