Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion "MITI-IA"

Terminated

Phase 2 Results N/A

Trial Description

The purpose of the trial is to evaluate the safety of microplasmin as well as its ability to open blocked arteries to the brain in patients with acute stroke when given into the artery at the site of the blockage.

Detailed Description

Patients with angiographically documented acute intracranial vertebrobasilar artery occlusion presenting within 24 hours of neurological symptom onset will be enrolled into this open-label trial. During study drug administration, angiograms will be repeated at regular intervals to determine degree of clot lysis.

Trial Stopped: Sponsor's decision not to pursue development of uPLi for vascular conditions.

Conditions

Interventions

  • Microplasmin Drug
    Intervention Desc: 2 mg/kg, IA over 75 mins
    ARM 1: Kind: Experimental
    Label: 1
    ARM 2: Kind: Experimental
    Label: Active

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Recanalization rate Day-7, Day-30 and Day-90 No
Secondary Clinical assessment Day-7, Day-30 and Day-90 No

Sponsors