The objective of this study is to evaluate the safety and effectiveness of the clinical and technical performance of the CorPath® 200 System in the delivery and manipulation of coronary guidewires and stent/balloon systems for use in percutaneous coronary interventions (PCI).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
164
CorPath 200® robotic-assisted percutaneous coronary intervention
Washington Hospital Center
Washington D.C., District of Columbia, United States
Northeast Georgia Heart Center
Gainesville, Georgia, United States
St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Columbia University Medical Center
New York, New York, United States
Saint Joseph's Hospital
Syracuse, New York, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
CORBIC
Medellín, Colombia
Percentage of Participants With Clinical Procedural Success
Defined as \<30% residual stenosis in CorPath 200 System treated lesions at the completion of the interventional procedure (including stent placement) in the absence of MACE, either within 48 hours of the procedure or prior to hospital discharge, whichever occurs first.
Time frame: 48-hrs or hospital discharge, whichever occurs first
Percentage of Patients With Device Technical Success
Defined as the successful advancement and retraction of PCI devices using the CorPath 200 System and without conversion to manual operation.
Time frame: 1 day
The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table
Defined as the difference between the radiation exposure measured at the procedure table (the conventional site of the primary operator) and the radiation exposure measured at the primary operator's position during the procedure. The radiation unit that was used was in milligray, but the measure is being reported as the ratio.
Time frame: 1 day
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