Evaluation of MST-188 in Acute Lower Limb Ischemia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of MST-188 in subjects receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether treatment with MST-188 results in more rapid thrombolysis of the occlusion and more rapid tissue perfusion in the effected blood vessel.

Official Title
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Evaluation of MST-188 in Acute Lower Limb Ischemia: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial Evaluating the Safety and Efficacy of MST-188 in Subjects With Acute Lower Limb Ischemia Receiving Catheter-Directed Recombinant Tissue Plasminogen Activator

Conditions
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Acute Limb Ischemia

Intervention / Treatment
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* Drug: MST-188
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥30 to <80 Symptoms consistent with ALI in target lower limb classified as Rutherford Category IIa or IIb Subject is hospitalized or in the process of hospitalization for the treatment of ALI Angiographic confirmation of thrombotic lower limb arterial occlusion Exclusion Criteria: Prosthetic bypass graft occlusion within 1 month of implantation or autogenous graft occlusion within 6 months of placement Treatment with a thrombolytic agent within the last 48 hours Subject's laboratory results indicate inadequate organ function NYHA Class IV congestive heart failure Prior major amputation of the target limb Other complications or contraindications for receiving rt-PA, anticoagulants, or contrast media

Ages Eligible for Study
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Minimum Age: 30 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline<br>Saline administered IV for 12 hours | Drug: Saline<br> <br> |
| Experimental: Lower Dose<br>MST-188 loading dose 100 mg/kg IV for 1 hour followed by 25 mg/kg/hr for 11 hours | Drug: MST-188<br> <br> * Other names: vepoloxamer;|
| Experimental: Higher Dose<br>MST-188 loading dose 200 mg/kg IV for 1 hour followed by 75 mg/kg/hr for 11 hours | Drug: MST-188<br> <br> * Other names: vepoloxamer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint) |  | Baseline, 8 and 24 hours | 
| Assessment of the change in TcPO2 (Exploratory endpoint) |  | Baseline, 8, 12, and 24 hours | 
| Number of participants with adverse events |  | Randomization through 30 days post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute limb ischemia, ALI, Acute lower extremity arterial occlusion