ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/23/2016 |
Start Date: | September 2013 |
End Date: | December 2017 |
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.
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.
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
We found this trial at
39
sites
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Florida Hospital Florida Hospital is one of the country
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Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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