PRECISION GRX Registry
A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions
1 other identifier
observational
952
4 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Typical duration for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 27, 2017
CompletedFirst Submitted
Initial submission to the registry
September 6, 2017
CompletedFirst Posted
Study publicly available on registry
September 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2020
CompletedOctober 19, 2020
October 1, 2020
2.4 years
September 6, 2017
October 15, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Clinical Success
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).
Discharge or 72 hours post intervention, whichever comes first.
Technical Success
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.
Procedure
Secondary Outcomes (4)
Overall Procedure Time
Procedure
PCI Procedure Time
Procedure
Fluoroscopy Time
Procedure
Patient Radiation Exposure
Procedure
Interventions
The CorPath GRX is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.
Eligibility Criteria
Subjects with coronary artery disease and with a clinical indication for PCI.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corindus Inc.lead
Study Sites (20)
UC San Diego Health Sulpizio Cardiovascular Center
San Diego, California, 92037, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Spectrum Health Hospitals Fred and Lena Meijer Heart Center
Grand Rapids, Michigan, 49503, United States
William Beaumont Hospital - Troy
Troy, Michigan, 48085, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
New York-Presbyterian Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
WakeMed Raleigh Campus
Raleigh, North Carolina, 27610, United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Wellspan York Hospital
York, Pennsylvania, 17405, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75226, United States
Baylor Scott and White All Saints Medical Center
Fort Worth, Texas, 76104, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
University of Virginia Health System University Hospital
Charlottesville, Virginia, 22903, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Albert Einstein Israelite Hospital
São Paulo, São Paulo, 05652-900, Brazil
Apex Heart Institute
Ahmedabad, Gujarat, 380059, India
Tan Tock Seng Hospital
Singapore, 308433, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ehtisham Mahmud, MD
University of California, San Diego
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Days
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2017
First Posted
September 11, 2017
Study Start
August 27, 2017
Primary Completion
February 6, 2020
Study Completion
February 6, 2020
Last Updated
October 19, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share