Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Phase 2TerminatedNCT00507806

ImaRx Therapeutics

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Acute Ischemic Stroke

Interventions

perflutren lipid microsphereDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of symptomatic intracranial hemorrhage

Time frame: 72 hours

Secondary Outcomes

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

Data from ClinicalTrials.gov

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