A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion

Inclusion Criteria: * Unilateral limb ischemia - Society of Vascular Surgery Categories I and IIa * Onset of symptoms less than or equal to 14 days * Thrombosed infrainguinal bypass graft or native artery * Diagnosis by arteriography of occlusive thrombus in graft or artery * Ability to embed the infusion catheter into the thrombus * Women of childbearing potential must use contraception and have a negative pregnancy test Exclusion Criteria: * Any medical or social condition that may interfere with study participation * Women who are pregnant or lactating * Hemorrhagic stroke history * Thrombotic or embolic stroke or cerebrovascular events (including transient ischemic attack) within one year * Intracranial or spinal neurosurgery, or severe intracranial trauma in the last 3 months * Major surgery, organ biopsy, or major trauma within the past 10 days * Lumbar puncture or non-compressible arterial puncture in the past 10 days * Intraocular surgery within the past 10 days * Active gastrointestinal or organ bleeding * Uncontrolled arterial hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) * Known intracranial neoplasm, aneurysm, or arteriovenous malformation * Current bleeding diathesis * Platelet count \<75 x 10e9/L * Active graft infection * Occlusion occurred within one month of synthetic graft placement * Occlusion occurred within 6 months of autologous graft placement * A sequential composite graft with dual outflows to correct multiple occlusions * Medically unable to tolerate an open vascular procedure * Known prothrombotic state * Hemoglobin \<10.0 g/dL * Impaired renal function or renal disease that constitutes a contraindication to contrast angiography, including creatinine \>2.0 mg/dL * Treatment with a full dose plasminogen activator (PA) within the last 48 hours * Treatment with a glycoprotein IIb/IIIa class of platelet inhibitor within the past 5 days * Treatment with oral anticoagulants, and with an international normalized ratio of \>1.7