ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

Overview

About this study

The primary objective of the study is to demonstrate that anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in subjects undergoing peripheral endovascular interventions (PEI). The secondary objective is to identify 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Subjects ≥ 18 years of age
  • Must be undergoing one of the following PEI procedures:
    • Carotid artery stenting (approximately 33% of study sample)
    • Lower Extremity Interventions (LEI) for Critical Limb Ischemia (CLI) (approximately 33% of study sample)
    • LEI for claudication (approximately 33% of study sample)
  • 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 kilograms (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 (PCI)
  • Any percutaneous coronary, endovascular, or structural heart disease procedure within 30 days prior to randomization
  • International normalized ratio (INR) >1.7 within 24 hours (h) prior to the index procedure
  • Administration of therapeutic doses of UFH within 30 minutes (min) prior to the index procedure (a low dose [≤2000 units (U)] of heparin is permitted during the diagnostic angiogram prior to the intervention)
  • Administration of enoxaparin within 8 hours; other low molecular weight heparins (LMWHs) or fondaparinux within 24 hours; any oral anti-Xa or antithrombin agent within 48 hours; or thrombolytics, glycoprotein inhibitors (GPI), or warfarin within 72 hours 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
  • Subjects who, for any reason, are deemed by the investigator to be inappropriate for this study

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Sanjay Misra, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20145054

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