Status:
TERMINATED
Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion
Lead Sponsor:
ThromboGenics
Conditions:
Arterial Occlusive Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of the trial is to evaluate the safety and efficacy of microplasmin administration in patients with acute peripheral arterial occlusion.
Detailed Description
This clinical trial is designed as an open-label, dose-escalating, single-centre trial of weight-adjusted dose regimens of microplasmin administered intra-arterially as an infusion to patients with ac...
Eligibility Criteria
Inclusion
- Patients presenting within 14 days of onset of acute thrombotic or embolic arterial occlusion of a lower extremity (native vessel or bypass graft).
- Complete occlusion of infrarenal vessel or bypass graft, as determined by angiography.
- Lower extremity ischemia graded as SVS/ISCS (Society of Vascular Surgery/ International Society for Cardiovascular Surgery) class I or II (a or b).
- Negative urine pregnancy test (pregnancy test only required for females of child-bearing potential not using an accepted method of contraception).
Exclusion
- Profound ischemia with permanent motor paresis or sensory loss (or ischemic process deemed irreversible, i.e. class III).
- Occlusion not penetrable by the infusion guide wire.
- Known or suspected allergy to contrast agents or heparin sodium.
- Active bleeding or known hemorrhagic diathesis.
- Stroke in the previous 6 months or transient ischemic attack in the previous 2 months.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00123292
Start Date
March 1 2005
End Date
November 1 2009
Last Update
April 7 2014
Active Locations (1)
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1
University Hospital Gasthuisberg
Leuven, Belgium, B-3000