Evaluation of MST-188 in Acute Lower Limb Ischemia

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