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Sponsor's decision not to pursue development of uPLi for vascular conditions.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microplasmin | Drug | 2 mg/kg, IA over 75 mins |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recanalization rate | Day-7, Day-30 and Day-90 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical assessment | Day-7, Day-30 and Day-90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Hamann, Prof. Dr | HSK Dr. Horst Schmidt Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Erlangen | Erlangen | D-91054 | Germany | |||
| Universitatsklinikum Freiburg |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C054561 | microplasmin |
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| Freiburg im Breisgau |
| D-79106 |
| Germany |
| Universitätsklinikum des Saarlandes | Homburg/Saar | 66421 | Germany |
| UKSH Campus Kiel | Kiel | 24105 | Germany |
| Ludwig-Maximilians-University Hospital | Munich | Germany |
| HSK Dr. Horst Schmidt Hospital | Wiesbaden | 65199 | Germany |
| Sint Antonius Ziekenhuis | Nieuwegein | 3430 EM | Netherlands |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |