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.
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.
- Microplasmin Drug
Intervention Desc: 2 mg/kg, IA over 75 mins ARM 1: Kind: Experimental Label: 1 ARM 2: Kind: Experimental Label: Active
- Allocation: Non-Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Single Group Assignment
|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|
- ThromboGenics Lead