Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke
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ClinicalTrials.gov Identifier: NCT00507806 |
Recruitment Status :
Terminated
(for administrative reasons)
First Posted : July 27, 2007
Last Update Posted : July 27, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Ischemic Stroke | Drug: perflutren lipid microsphere | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke |
Study Start Date : | March 2005 |
Actual Study Completion Date : | May 2006 |

- Drug: perflutren lipid microsphere
Other Name: Definity
- Incidence of symptomatic intracranial hemorrhage [ Time Frame: 72 hours ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507806
Principal Investigator: | Andrei Alexandrov, MD | The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00507806 |
Other Study ID Numbers: |
MRX-815-401 |
First Posted: | July 27, 2007 Key Record Dates |
Last Update Posted: | July 27, 2007 |
Last Verified: | July 2007 |
Acute Ischemic Stroke Microbubbles Transcranial Doppler ultrasound TIBI |
Symptomatic Intracranial Hemorrhage modified Rankin Scale Recanalization Perflutren |
Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia |