This clinical trial is for men and women who will be treated with peripheral endovascular interventions (PEI).
The purpose of the study is to determine whether anticoagulation treatment with a drug called bivalirudin (manufactured by The Medicines Company under the trade name Angiomax®) results in fewer major bleeding complications compared with heparin in subjects undergoing PEI. Bivalrudin is an anticoagulant that may overcome many limitations seen with indirect thrombin inhibitors, such as heparin, by having a more predictable response, leaving the body more quickly, and avoiding conditions associated with the use of heparin such as thrombocytopenia.
Study subjects will be followed up for 12 months after the peripheral endovascular interventions .
Men and women age 18 and older who are undergoing one of the following peripheral endovascular interventions (PEI) may enroll in this study:
- Carotid artery stenting
- Lower Extremity Interventions (LEI) for Critical Limb Ischemia (CLI)
- Lower Extremity Interventions (LEI) for claudication (a condition in which cramping pain in the leg is induced by exercise, typically caused by obstruction of the arteries)
Detailed eligibility requirements will be reviewed when you contact the study team.
Dolores Reynolds, R.N., phone 212-746-4617, email dtr2001@med.cornell.edu
ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial. ClinicalTrials.gov Identifier NCT01913483