Clinical Trials and Studies

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A Phase 2, Randomized, Open-label (With Blinded Plasminogen Activator and Placebo Control Groups) Study to Evaluate the Effects of Different Intra-thrombus Infusion Regimens of Plasmin (Human) Compared to Plasminogen Activator and Placebo In Patients With Acute Lower Extremity Native Artery or Bypass Graft Occlusion


The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing different delivery regimens in patients with peripheral arterial occlusion. The study includes a blinded plasminogen activator treatment group and a blinded plasminogen activator placebo group. The study will also assess safety and tolerability of Plasmin at 150 and 250 mg doses.


Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion 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

  • 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


  • Slovakia

    • Oddelenie diagnostickej a intervencnej radiologie, The National Institute of Cardiovascular Diseases, Bratislava, 83348
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