Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

ImaRx Therapeutics

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Acute Ischemic Stroke

Treatments: Drug: perflutren lipid microsphere

Study type: Interventional

Funder types: Industry

Identifiers

NCT00507806

MRX-815-401

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)