Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00507806

Enrollment

Unknown

Registered

2007-07-27

Start date

2005-03-31

Completion date

2006-05-31

Last updated

2007-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke, Microbubbles, Transcranial Doppler ultrasound, TIBI, Symptomatic Intracranial Hemorrhage, modified Rankin Scale, Recanalization, Perflutren

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.

Interventions

DRUGperflutren lipid microsphere

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of symptomatic intracranial hemorrhage	72 hours

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026