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 OCCLUSIO

Not Applicable

Conditions: -I738 Other specified peripheral vascular diseases
Other specified peripheral vascular diseases
I738

Registration Number: PER-100-10

Lead Sponsor: TALECRIS BIOTHERAPEUTICS, INC,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 5

Inclusion Criteria

• Unilateral limb ischemia: symptomatic. Categories I and IIa of Acute Ischemia SCV
• onset of symptoms <14 days
• Infrainguinal graft (synthetic mixed, autologous or one outlet) thrombosed (non-embolic) or infrainguinal native artery. In the case of native arteries, occlusions of> 10cm in length are eligible.
• Diagnosis of thrombus with occlusion in the graft or artery by means of an arteriography after informed consent has been obtained
• Ability to access the thrombus with the infusion catheter and successfully insert the infusion segment of the infusion catheter.
• The subject must be able to sign their informed consent before participating in the study.
• Age> 18 years
• In the case of women of childbearing age, they must use an appropriate method of contraception during the study period and must have a negative pregnancy outcome before participating in the study.

Exclusion Criteria

• Any medical or social condition that may interfere with the completion of the study by the subject.
• Pregnant or nursing women, or who are in the first 10 days of postpartum.
• Cardiopulmonary resuscitation in the previous year
• Previous systemic or anaphylactoid allergies to contrast agent, streptokinase or blood components (those allergic to shellfish or iodine may enter the study).
• Not eligible for thrombolytic treatment for any reason
• Active graft infection
• Occlusion occurred within the first month of placement of the synthetic graft
• Occlusion occurred within the first six months of autologous graft placement
• A sequential mixed dual-exit graft to correct multiple occlusions
• In the opinion of the Researcher, he is clinically unable to tolerate an open vascular procedure
• History of prothrombotic state, such as anticardiopillin antibody, peripheral vascular disease associated with acquired immunodeficiency virus (HIV)
• History of contraindication to heparin (eg, history of heparin-induced thrombocytopenia)
• Hemoglobin <10.0 g / dl (if the selection shows low hemoglobin with no active bleeding, this can be corrected by transfusion). The hemoglobin test can be taken again.
• Impaired renal function or renal disease that constitutes a contraindication to contrast arteriography, including a creatinine level> 2.0 mg / dL in the baseline selection / evaluation. The creatinine test can be taken again after hydration by prerenal azotemia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Percentage of subjects with a thrombolysis of <50%, 51% to 75%, 76% to 90%,> 90%.<br>Measure:Thrombolysis at the end of treatment compared to baseline evaluation<br>Timepoints:90 days<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Avoid major surgical revascularization, mechanical thrombectomy, and CDT with additional BP in the affected limb from the end of treatment until Day 30.<br>Measure:Avoid major surgical revascularization, mechanical thrombectomy, and CDT with additional BP in the affected limb from the end of treatment until Day 30.<br>Timepoints:90 days<br>;<br>Outcome name:Blood flow in the native artery or graft under treatment, by ultrasound at the end of the treatment or post intervention and Day 30.<br>Measure:Blood flow in the native artery or graft under treatment, by ultrasound at the end of the treatment or post intervention and Day 30.<br>Timepoints:Day 30<br>;<br>Outcome name:Ischemic signs or symptoms of pain, paraesthesia, paralysis, poikilothermia, paleness and absence of pulse from baseline evaluation to the end of treatment<br>Measure:Appearance of signs or symptoms<br>Timepoints:During treatment<br>