- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03278301
PRECISION GRX Registry
October 15, 2020 updated by: Corindus Inc.
A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
952
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sao Paulo
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São Paulo, Sao Paulo, Brazil, 05652-900
- Albert Einstein Israelite Hospital
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Gujarat
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Ahmedabad, Gujarat, India, 380059
- Apex Heart Institute
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Singapore, Singapore, 308433
- Tan Tock Seng Hospital
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California
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San Diego, California, United States, 92037
- UC San Diego Health Sulpizio Cardiovascular Center
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District of Columbia
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Washington, District of Columbia, United States, 20010
- MedStar Washington Hospital Center
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Spectrum Health Hospitals Fred and Lena Meijer Heart Center
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Troy, Michigan, United States, 48085
- William Beaumont Hospital - Troy
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Missouri
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Kansas City, Missouri, United States, 64111
- St. Luke's Hospital of Kansas City
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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New York, New York, United States, 10032
- New York-Presbyterian Columbia University Medical Center
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North Carolina
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Raleigh, North Carolina, United States, 27610
- WakeMed Raleigh Campus
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19141
- Einstein Medical Center
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York, Pennsylvania, United States, 17405
- Wellspan York Hospital
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Tennessee
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Jackson, Tennessee, United States, 38301
- Jackson-Madison County General Hospital
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Texas
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Dallas, Texas, United States, 75226
- Baylor Jack and Jane Hamilton Heart and Vascular Hospital
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Fort Worth, Texas, United States, 76104
- Baylor Scott and White All Saints Medical Center
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Houston, Texas, United States, 77030
- Houston Methodist Hospital
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Plano, Texas, United States, 75093
- The Heart Hospital Baylor Plano
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Virginia
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Charlottesville, Virginia, United States, 22903
- University of Virginia Health System University Hospital
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Washington
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Seattle, Washington, United States, 98195
- University of Washington Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects with coronary artery disease and with a clinical indication for PCI.
Description
Inclusion Criteria:
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 Criteria:
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Success
Time Frame: Discharge or 72 hours post intervention, whichever comes first.
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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).
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Discharge or 72 hours post intervention, whichever comes first.
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Technical Success
Time Frame: Procedure
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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.
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Procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Procedure Time
Time Frame: Procedure
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Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
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Procedure
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PCI Procedure Time
Time Frame: Procedure
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Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
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Procedure
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Fluoroscopy Time
Time Frame: Procedure
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Total Fluoroscopy Time during procedure will be captured.
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Procedure
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Patient Radiation Exposure
Time Frame: Procedure
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DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.
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Procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 27, 2017
Primary Completion (ACTUAL)
February 6, 2020
Study Completion (ACTUAL)
February 6, 2020
Study Registration Dates
First Submitted
September 6, 2017
First Submitted That Met QC Criteria
September 7, 2017
First Posted (ACTUAL)
September 11, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 19, 2020
Last Update Submitted That Met QC Criteria
October 15, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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