Coronary Artery DiseaseNCT03278301
PRECISION GRX Registry
An observational study of Coronary Artery Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 20 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Robotic-assisted PCI
- Type of treatment
- Medical device
- How many people
- 952 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 27 Aug 2017to 6 Feb 2020
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with coronary artery disease and with a clinical indication for PCI.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United States17 sites
University of Virginia Health System University Hospital
Charlottesville, Virginia, 22903
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75226
Baylor Scott and White All Saints Medical Center
Fort Worth, Texas, 76104
Spectrum Health Hospitals Fred and Lena Meijer Heart Center
Grand Rapids, Michigan, 49503
Houston Methodist Hospital
Houston, Texas, 77030
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
New York-Presbyterian Columbia University Medical Center
New York, New York, 10032
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
The Heart Hospital Baylor Plano
Plano, Texas, 75093
WakeMed Raleigh Campus
Raleigh, North Carolina, 27610
UC San Diego Health Sulpizio Cardiovascular Center
San Diego, California, 92037
University of Washington Medical Center
Seattle, Washington, 98195
Montefiore Medical Center
The Bronx, New York, 10467
William Beaumont Hospital - Troy
Troy, Michigan, 48085
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Wellspan York Hospital
York, Pennsylvania, 17405
Brazil1 site
Albert Einstein Israelite Hospital
São Paulo, São Paulo, 05652-900
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Robotic-assisted PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted PCIDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Procedure
Secondary outcomes (4)
Overall Procedure Time
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Measured: Procedure
PCI Procedure Time
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Measured: Procedure
Fluoroscopy Time
Total Fluoroscopy Time during procedure will be captured.
Measured: Procedure
Patient Radiation Exposure
DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start27 Aug 2017
- Primary completion6 Feb 2020
- Study completion6 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 952 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ehtisham Mahmud, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278301
- Sponsor's protocol ID
- 2017-001
- Status last verified
- Oct 2020
- First submitted
- 6 Sep 2017
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT03278301
- Acronym / sponsor ID
- 2017-001
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 952 participants (actual)
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2017 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with coronary artery disease and with a clinical indication for PCI.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Candidates will be excluded from the study if any of the following conditions are present:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted PCIThe 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. | Device | – |
Primary outcome
Clinical Success
Time frame: 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
Time frame: 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.
4 secondary outcomes
Overall Procedure Time
Time frame: Procedure
PCI Procedure Time
Time frame: Procedure
Fluoroscopy Time
Time frame: Procedure
Patient Radiation Exposure
Time frame: Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ehtisham Mahmud, MD principal investigator
University of California, San Diego
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Brazil, India, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success (time frame: Discharge or 72 hours post intervention, whichever comes first.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.