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
Results First Posted : December 2, 2020
Last Update Posted : December 22, 2020
|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
- Number of Participants With 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).
- Number of Participants With 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.
- Number of Participants With an Adverse Event [ 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.
- Contrast Fluid Volume [ Time Frame: During procedure ]The amount of contrast fluid used (mL) during the procedure.
- Patient Radiation Exposure - Dose-Area-Product [ Time Frame: During procedure ]DAP (dose-area-product) as recorded during the procedure.
- Patient Radiation Exposure - Cumulative Dose [ Time Frame: During procedure ]Cumulative dose (mGy) as recored during the procedure.
- Number of Participants Who Had a Conversions to Manual Technique. [ 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.
- Visual Measurement of Lesion Length [ Time Frame: During procedure ]Visual estimate by clinical operator prior to delivery of PCI device(s).
- CorPath Measurement of Lesion Length [ Time Frame: During procedure ]Robotic measurement of lesion length using the CorPath System performed by the Clinical Operator.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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, 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|