ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
Condition: Peripheral Endovascular Interventions; Bleeding
Intervention: Bivalirudin; Unfractionated Heparin
Intervention description: Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion.; Unfractionated heparin is an anticoagulant.
Intervention MeSH terms: Heparin; Calcium heparin; Bivalirudin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 732.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to test whether anticoagulation with bivalirudin
      results in fewer major bleeding complications compared with unfractionated heparin (UFH) in
      participants undergoing peripheral endovascular interventions (PEI). The secondary objective
      is to test whether there were potential benefits from bivalirudin therapy on other clinically
      important events such as death, myocardial infarction (MI), stroke and/or transient ischemic
      attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as
      well as potential economic benefits that may result from improved clinical outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants ≥ 18 years of age

          -  Must be undergoing one of the following PEI procedures:

               -  Carotid artery stenting

               -  Lower Extremity Interventions (LEI) for Critical Limb Ischemia

               -  LEI for claudication

          -  Provide written informed consent prior to any study-specific procedure being performed

        Exclusion Criteria:

          -  Any known contra-indication to the use of bivalirudin or UFH

          -  Acute limb ischemia

          -  Planned amputation regardless of the outcome of the PEI

          -  Dialysis dependent

          -  Weight less than 38 kg or more than 202 kg

          -  History of any bleeding diathesis or severe hematological disease

          -  History of intra-cranial: mass, aneurysm, arteriovenous malformation or hemorrhage

          -  Gastrointestinal or genitourinary bleeding within the 30 days prior to randomization

          -  Any surgery (excluding punch or shave skin biopsy) within the 30 days prior to
             randomization

          -  Concomitant percutaneous coronary intervention

          -  Any percutaneous coronary, endovascular, or structural heart disease procedure within
             30 days prior to randomization

          -  International normalized ratio >1.7 within 24 h prior to the index procedure

          -  Administration of therapeutic doses of UFH within 30 min prior to the index procedure
             (a low dose [≤2000 U] of heparin is permitted during the diagnostic angiogram prior to
             the intervention)

          -  Administration of enoxaparin within 8 h; other low molecular weight heparins or
             fondaparinux within 24 h; any oral anti-Xa or antithrombin agent within 48 h; or
             thrombolytics, glycoprotein inhibitors, or warfarin within 72 h prior to the index
             procedure

          -  Severe contrast allergy that cannot be pre-medicated

          -  Procedures performed by radial access when they are intended as the primary access
             site for the index procedure

          -  Known or suspected pregnant women or nursing mothers

          -  Previous enrollment in this study (MDCO-BIV-12-03)

          -  Participation in other investigational drug or device trials within 30 days prior to
             randomization

          -  Participants who, for any reason, are deemed by the investigator to be inappropriate
             for this study