Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Terminated

Phase 1/2 Results N/A

Trial Description

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.

Trial Stopped: for administrative reasons

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of symptomatic intracranial hemorrhage 72 hours
Secondary Complete recanalization of the occluded artery (TIBI 4-5) End of treatment
Secondary NIHSS score of 0-2 24 hours
Secondary Favorable outcome (modified Rankin Scale or NIHSS 0-1) 3 months

Sponsors