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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Sanjay Misra, M.D.	Closed for enrollment

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

Clinical Trials