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

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