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

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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.


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
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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8900 North Kendall Drive
Miami, Florida 33176
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Miami, FL
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Albuquerque, New Mexico 87102
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Alexandria, Virginia 22304
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Anderson, South Carolina 29621
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Ashland, KY
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Boston, Massachusetts 02130
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Browns Mills, New Jersey 08015
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171 Ashley Avenue
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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Charlotte, North Carolina 28204
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Clearwater, FL
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Davenport, IA
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Gainesville, Florida 32605
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Gainesville, Florida 32605
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Greensboro, North Carolina 27401
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Hot Springs, Arkansas 71901
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Hyannis, Massachusetts 02601
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Lubbock, Texas 79430
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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New York, New York 10021
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Ogden, Utah 84403
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Oklahoma City, Oklahoma
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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Rochester, Minnesota 55905
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Standford, California 94305
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Stony Brook, New York 11794
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Teaneck, New Jersey 07666
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Temple, Texas 76508
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Toledo, Ohio 43606
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Ypsilanti, Michigan 48197
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