Stroke
Conditions
Keywords
stroke, vertebrobasilar, basilar, Acute vertebrobasilar artery occlusion
Brief summary
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.
Interventions
DRUGMicroplasmin
2 mg/kg, IA over 75 mins
Sponsors
ThromboGenics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with angiographically documented vertebrobasilar artery occlusion 2. Initiation of study drug treatment within 24 hours of the onset of neurological symptoms 3. Age 18-75 (inclusive).
Exclusion criteria
1. Patients with coma \> 6 hrs duration and complete loss of brain stem reflexes (corneal reflex, gag reflex, VOR, pupil reflexes) as measured at the last assessment before sedation/intubation 2. Rapidly improving neurologic signs at any time before initiation of study drug administration. 3. Known contrast agent-sensitivity 4. Uncontrolled hypertension defined as a systolic blood pressure \> 180 mm Hg or a diastolic blood pressure \> 100 mm Hg on 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy. 5. History of stroke within the previous 6 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recanalization rate | Day-7, Day-30 and Day-90 |
Secondary
| Measure | Time frame |
|---|---|
| Clinical assessment | Day-7, Day-30 and Day-90 |
Countries
Germany, Netherlands
Outcome results
None listed