Status:
TERMINATED
Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion
Lead Sponsor:
ThromboGenics
Conditions:
Stroke
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
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. Duri...
Eligibility Criteria
Inclusion
- Patients with angiographically documented vertebrobasilar artery occlusion
- Initiation of study drug treatment within 24 hours of the onset of neurological symptoms
- Age 18-75 (inclusive).
Exclusion
- 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
- Rapidly improving neurologic signs at any time before initiation of study drug administration.
- Known contrast agent-sensitivity
- 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.
- History of stroke within the previous 6 weeks.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00123266
Start Date
December 1 2006
End Date
August 1 2008
Last Update
April 7 2014
Active Locations (7)
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1
Universitätsklinikum Erlangen
Erlangen, Germany, D-91054
2
Universitatsklinikum Freiburg
Freiburg im Breisgau, Germany, D-79106
3
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany, 66421
4
UKSH Campus Kiel
Kiel, Germany, 24105