Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions (PRECISION)
To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath 200 System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters during PCI procedures.
Coronary Artery Disease
Arterial Occlusive Diseases
Procedure: CorPath-assisted Percutaneous Coronary Intervention
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort|
|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|
- Clinical Success [ Time Frame: In-hospital (72 hours or discharge, whichever occurs first) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]As recorded by an X-Ray System utilized during the procedure.
- Patient Radiation Exposure [ Time Frame: During procedure ] [ Designated as safety issue: No ]DAP (dose-area-product) and cumulative dose as recorded during the procedure.
- Contrast Fluid Volume [ Time Frame: During procedure ] [ Designated as safety issue: No ]No additional description
- Number of Conversions to Manual [ Time Frame: During procedure ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- 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
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
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
This is a prospective, single-arm, open-label, multi-center patient registry of the CorPath 200 System to examine its performance during PCI procedure and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01917682
|Contact: Chris Cain, RN||(508) 653-3335 ext firstname.lastname@example.org|
|United States, California|
|UC San Diego Medical Center||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Bahman Ghannadian email@example.com|
|Principal Investigator: Ehtisham Mahmud, MD|
|United States, Colorado|
|Valley View Hospital||Recruiting|
|Glenwood Springs, Colorado, United States, 81601|
|Contact: Kim Williams Kim.Williams@vvh.org|
|Principal Investigator: Frank A. Laws, MD|
|United States, Florida|
|Orlando Regional Medical Center||Recruiting|
|Orlando, Florida, United States, 32806|
|Contact: Yozandra Parrimon Yozandra.Parrimon@orlandohealth.com|
|Principal Investigator: Vijaykumar Kasi, MD|
|United States, Georgia|
|North Georgia Heart Foundation||Recruiting|
|Gainesville, Georgia, United States, 30501|
|Contact: Donna Patrick, RN firstname.lastname@example.org|
|Principal Investigator: Mark Leimbach, MD|
|United States, Massachusetts|
|St. Elizabeth's Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02135|
|Contact: Lindsay Pothier Lindsay.Pothier@steward.org|
|Principal Investigator: Joseph P. Carrozza, MD|
|United States, Michigan|
|Spectrum Health System||Recruiting|
|Grand Rapids, Michigan, United States, 49503|
|Contact: Ryan Sagorski Ryan.Sagorski@spectrumhealth.org|
|Principal Investigator: David Wohns, MD|
|United States, New York|
|Columbia University Medical Center/New York-Presbyterian Hospital||Recruiting|
|New York, New York, United States, 10032|
|Contact: Andy Morales email@example.com|
|Principal Investigator: Jeffrey Moses, MD|
|St. Joseph's Hospital Health Center||Recruiting|
|Syracuse, New York, United States, 13203|
|Contact: Tamer Ghobrial firstname.lastname@example.org|
|Principal Investigator: Ronald Caputo, MD|
|United States, North Carolina|
|Carolinas Medical Center - Northeast||Recruiting|
|Concord, North Carolina, United States, 28203|
|Contact: Janet Patterson email@example.com|
|Principal Investigator: Paul Campbell, MD|
|United States, Ohio|
|University Hospitals Case Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Hiram Bezerra, MD hiram.bezerra@UHhospitals.org|
|Principal Investigator: Hiram Bezerra, MD|
|United States, South Dakota|
|Sioux Falls, South Dakota, United States, 57104|
|Contact: Amy Wittrock firstname.lastname@example.org|
|Principal Investigator: Tomasz Stys, MD|
|United States, Virginia|
|Virginia Commonwealth Univ. Medical Center||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Laura Cei email@example.com|
|Principal Investigator: George Vetrovec, MD|
|Shaare Zedek Medical Center||Recruiting|
|Jerusalem, Israel, 91031|
|Contact: Astrid Rojansky firstname.lastname@example.org|
|Principal Investigator: Giora Weisz, MD|
|Principal Investigator:||Giora Weisz, MD||Columbia University Medical Center/New York-Presbyterian Hospital|
|Study Director:||Chris Cain||VP, Clinical Affairs|