Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The Medicines Company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
