Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion

Study Overview
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Brief Summary
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The purpose of the trial is to evaluate the safety and efficacy of microplasmin administration in patients with acute peripheral arterial occlusion.

Detailed Description
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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 acute peripheral arterial occlusion. Patients who meet all inclusion criteria and none of the exclusion criteria will be administered study drug for up to 4 hours. Different dose regimens will be evaluated in an ascending-dose fashion; an infusion will be administered for up to 4 hours.

Official Title
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An Open-label, Ascending-dose, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Peripheral Arterial Occlusion

Conditions
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Arterial Occlusive Diseases

Intervention / Treatment
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* Drug: Microplasmin
* Drug: Microplasmin
* Drug: Microplasmin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Microplasmin<br>* An infusion of 0.45, 0.60 and 0.90 mg/kg/hr will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion).<br>|
| Experimental: 2<br> | Drug: Microplasmin<br>* An infusion of 0.45, 0.60 and 0.90 mg/kg/hr will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion).<br>|
| Experimental: 3<br> | Drug: Microplasmin<br>* An infusion of 0.45, 0.60 and 0.90 mg/kg/hr will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion).<br>|
| Experimental: 4a<br> | Drug: Microplasmin<br>* An infusion of 0.45 mg/kg/hr in conjunction with distal protection device will be administered for up to 4 hours. Study drug will be administered intra-arterially (into the thrombotic occlusion).<br>|
| Experimental: 4b<br> | Drug: Microplasmin<br>* An infusion of 20 or 40 mg (20 mg for the 15 cm treatment length device; 40 mg for the 30 cm treatment length device) over 10 minutes via the Trellis-8 Peripheral Infusion System catheter, in accordance with the Trellis-8 Instructions for Use. For occlusive lesions that are longer than the treatment length of the Trellis-8 device, a repeat infusion of the same dose and duration may be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete clot-lysis (defined as >95% estimated clot volume reduction compared to baseline angiogram) |  | at 4 hours or less (if study drug administration is terminated prior to 4 hours). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with clot-lysis (complete or partial, defined as any clot volume reduction on angiography) |  | At 4 hours or less (if study drug administration is terminated prior to 4 hours). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arterial occlusion, thromboembolism, Acute Peripheral Arterial Occlusion