Study Stopped
Sponsor's decision not to pursue development of uPLi for vascular conditions.
Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion
MITI-IA
An Open-label, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion
1 other identifier
interventional
2
2 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 stroke
Started Dec 2006
Shorter than P25 for phase_2 stroke
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2005
CompletedFirst Posted
Study publicly available on registry
July 22, 2005
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedApril 7, 2014
April 1, 2014
7 months
July 21, 2005
April 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recanalization rate
Day-7, Day-30 and Day-90
Secondary Outcomes (1)
Clinical assessment
Day-7, Day-30 and Day-90
Study Arms (1)
Active
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ThromboGenicslead
Study Sites (7)
Universitätsklinikum Erlangen
Erlangen, D-91054, Germany
Universitatsklinikum Freiburg
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerhard Hamann, Prof. Dr
HSK Dr. Horst Schmidt Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2005
First Posted
July 22, 2005
Study Start
December 1, 2006
Primary Completion
July 1, 2007
Study Completion
August 1, 2008
Last Updated
April 7, 2014
Record last verified: 2014-04