PRECISION GRX Registry
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT03278301
- Lead Sponsor
- Corindus Inc.
- Brief Summary
To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath GRX System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.
- Detailed Description
This is a single-arm, open-label, multi-center patient registry of the CorPath GRX System to examine its performance during PCI procedures and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 952
Candidates will be included in the study only if all of the following conditions are met:
- Age ≥18 years;
- Patients with coronary artery disease with clinical indication for PCI;
- Patient deemed appropriate for robotic-assisted PCI; and
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
-
Candidates will be excluded from the study if any of the following conditions are present:
- Failure/inability/unwillingness to provide informed consent; or
- The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Success Discharge or 72 hours post intervention, whichever comes first. Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse coronary events (MACE).
Technical Success Procedure Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.
- Secondary Outcome Measures
Name Time Method Overall Procedure Time Procedure Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Fluoroscopy Time Procedure Total Fluoroscopy Time during procedure will be captured.
Patient Radiation Exposure Procedure DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.
PCI Procedure Time Procedure Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Trial Locations
- Locations (20)
Albert Einstein Israelite Hospital
🇧🇷São Paulo, Sao Paulo, Brazil
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
UC San Diego Health Sulpizio Cardiovascular Center
🇺🇸San Diego, California, United States
Jackson-Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Spectrum Health Hospitals Fred and Lena Meijer Heart Center
🇺🇸Grand Rapids, Michigan, United States
New York-Presbyterian Columbia University Medical Center
🇺🇸New York, New York, United States
Baylor Scott and White All Saints Medical Center
🇺🇸Fort Worth, Texas, United States
WakeMed Raleigh Campus
🇺🇸Raleigh, North Carolina, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
University of Virginia Health System University Hospital
🇺🇸Charlottesville, Virginia, United States
Apex Heart Institute
🇮🇳Ahmedabad, Gujarat, India
St. Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Wellspan York Hospital
🇺🇸York, Pennsylvania, United States
William Beaumont Hospital - Troy
🇺🇸Troy, Michigan, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States