Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Crossing of the CTO with the BridgePoint Medical System and subsequent treatment of the CTO via PTA (specific devices to be used for PTA at investigators' discretion)
St. Luke's Medical Center
Phoenix, Arizona, United States
University of Southern California Medical Center
Los Angeles, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
Incidence of Patients with a Major Adverse Events (MAE)
MAE is defined as death, major unplanned amputation, perforation requiring intervention, or target lesion revascularization due to complication.
Time frame: 30 Day
Incidence of Intraprocedural Technical Success
Technical success is defined as the placement of a guidewire in the true lumen distal to the CTO
Time frame: Intraprocedural (<24 hours)
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University of Colorado Denver
Denver, Colorado, United States
Emory University Medical Center
Atlanta, Georgia, United States
Prairie Cardiovascular Consultants
Springfield, Illinois, United States
Columbia University Medical Center
New York, New York, United States
Wake Heart Center
Raleigh, North Carolina, United States
Dallas VA Medical Center
Dallas, Texas, United States
St. Joseph Hospital
Bellingham, Washington, United States