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TerminatedNCT00507806Updated Jul 27, 2007

Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

A Phase 1/2 interventional study of perflutren lipid microsphere in Acute Ischemic Stroke, sponsored by ImaRx Therapeutics. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-07-27.

Sponsored by ImaRx Therapeutics · Phase 1/2, Interventional, and Treatment

Why this study was terminated
for administrative reasons
Phase
Phase 1/2
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Ischemic Stroke

Keywords

  • Acute Ischemic Stroke
  • Microbubbles
  • Transcranial Doppler ultrasound
  • TIBI
  • Symptomatic Intracranial Hemorrhage
  • modified Rankin Scale
  • Recanalization
  • Perflutren
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

Browse Stroke studies →

Lead sponsor

ImaRx Therapeutics is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Right to left cardiac shunt
  • Uncontrolled hypertension
  • Absent temporal windows
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Interventions

  • Drugperflutren lipid microsphere

    Also known as: Definity

06

What researchers measure

Primary outcomes

  1. Incidence of symptomatic intracranial hemorrhage

    Time frame: 72 hours

Secondary outcomes

  1. Complete recanalization of the occluded artery (TIBI 4-5)

    Time frame: End of treatment

  2. NIHSS score of 0-2

    Time frame: 24 hours

  3. Favorable outcome (modified Rankin Scale or NIHSS 0-1)

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Alexandrov AV, Molina CA, Grotta JC, Garami Z, Ford SR, Alvarez-Sabin J, Montaner J, Saqqur M, Demchuk AM, Moye 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. doi: 10.1056/NEJMoa041175. PubMed 15548777 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00507806
Lead sponsor
ImaRx Therapeutics
First posted
Jul 27, 2007
Start date
Mar 2005
Completion
May 2006
Last update
Jul 27, 2007

Study contacts

Andrei Alexandrov, MD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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