Status:
COMPLETED
PRECISION GRX Registry
Lead Sponsor:
Corindus Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
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 guide...
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 hospi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 27 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 6 2020
Estimated Enrollment :
952 Patients enrolled
Trial Details
Trial ID
NCT03278301
Start Date
August 27 2017
End Date
February 6 2020
Last Update
October 19 2020
Active Locations (20)
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1
UC San Diego Health Sulpizio Cardiovascular Center
San Diego, California, United States, 92037
2
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Spectrum Health Hospitals Fred and Lena Meijer Heart Center
Grand Rapids, Michigan, United States, 49503
4
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48085