Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions (PRECISION)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01917682|
Recruitment Status : Completed
First Posted : August 7, 2013
Last Update Posted : June 12, 2017
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases||Procedure: CorPath-assisted Percutaneous Coronary Intervention|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||754 participants|
|Target Follow-Up Duration:||3 Days|
|Official Title:||A Post-Market Registry for the Evaluation of the CorPath 200 System Effectiveness in Percutaneous Coronary Interventions|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)
Procedure: CorPath-assisted Percutaneous Coronary Intervention
Robotic-assisted Percutaneous Coronary Intervention
Other Name: Robotic-assisted Percutaneous Coronary Intervention
- Clinical Success [ Time Frame: In-hospital (72 hours or discharge, whichever occurs first) ]Less than 30% residual stenosis post PCI in the lesion(s) treated with the CorPath system, without in-hospital major adverse coronary events (MACE).
- In-hospital Major Adverse Coronary Events (MACE) [ Time Frame: In-hospital (72 hours or discharge, whichever occurs first) ]The composite of death, myocardial infarction, and target vessel revascularization that occurs within 72 hours of the procedure or prior to hospital discharge, whichever occurs first, in a subject treated with the CorPath 200 System.
- Adverse Events [ Time Frame: In-hospital (72 hours or discharge, whichever occurs first) ]All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) from the start of the CorPath procedure until the end of the study will be summarized.
- Overall Procedure Time [ Time Frame: During procedure ]Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
- PCI Procedure Time [ Time Frame: During procedure ]Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
- Fluoroscopy and/or X-Ray Time [ Time Frame: During procedure ]As recorded by an X-Ray System utilized during the procedure.
- Patient Radiation Exposure [ Time Frame: During procedure ]DAP (dose-area-product) and cumulative dose as recorded during the procedure.
- Contrast Fluid Volume [ Time Frame: During procedure ]No additional description
- Number of Conversions to Manual [ Time Frame: During procedure ]The overall number of conversions from the robotic PCI to manual PCI will be captured to analyze the technical success of the device.
- Measurement of Lesion and Stented Segment Length [ Time Frame: During procedure ]
- Visual estimate by clinical operator prior to delivery of PCI device(s).
- CorPath 200 System measurement of the segment planned for treatment and length of deployed stent.
- Quantitative Coronary Angiography (QCA) of stented segment length
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917682
|United States, California|
|UC San Diego Medical Center|
|San Diego, California, United States, 92103|
|United States, Colorado|
|Valley View Hospital|
|Glenwood Springs, Colorado, United States, 81601|
|United States, District of Columbia|
|Medstar Washington Hospital Center|
|Washington, D.C., District of Columbia, United States, 20010|
|United States, Florida|
|Orlando Regional Medical Center|
|Orlando, Florida, United States, 32806|
|United States, Georgia|
|North Georgia Heart Foundation|
|Gainesville, Georgia, United States, 30501|
|United States, Massachusetts|
|St. Elizabeth's Medical Center|
|Boston, Massachusetts, United States, 02135|
|United States, Michigan|
|Spectrum Health System|
|Grand Rapids, Michigan, United States, 49503|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55906|
|United States, New York|
|Columbia University Medical Center/New York-Presbyterian Hospital|
|New York, New York, United States, 10032|
|St. Joseph's Hospital Health Center|
|Syracuse, New York, United States, 13203|
|United States, North Carolina|
|Carolinas Medical Center - Northeast|
|Concord, North Carolina, United States, 28203|
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|United States, South Dakota|
|Sioux Falls, South Dakota, United States, 57104|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Virginia Commonwealth Univ. Medical Center|
|Richmond, Virginia, United States, 23298|
|Shaare Zedek Medical Center|
|Jerusalem, Israel, 91031|
|Principal Investigator:||Giora Weisz, MD||Columbia University Medical Center/New York-Presbyterian Hospital|
|Study Director:||Chris Cain||VP, Clinical Affairs|