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STEMI - ST Elevation Myocardial InfarctionTREAT GRXNCT04459299

CorPath GRX STEMI Study

An observational study of STEMI - ST Elevation Myocardial Infarction and CAD, run by Siemens Healthineers Endovascular Robotics, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will evaluate the performance of the CorPath GRX System in Robotic Primary PCI (RPPCI) in the treatment of ST-elevated myocardial infarction (STEMI). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Robotic-PCI (CorPath GRX System)
Type of treatment
Medical device
How many people
3 participants
Where
1 siteUnited States
Study dates
28 Sep 2020to 29 Nov 2020
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects with a clinical indication of STEMI.

Who may be able to join

  • Age ≥18 and ≤ 80 years
  • Patients with STEMI<12 h of symptom onset
  • Patient deemed appropriate for robotic-assisted PCI
  • The subject has been informed of the nature of the study, agrees to its provisions, and has provided written consent

Who cannot join

  • Cardiogenic shock
  • Cardiac arrest
  • Need for manual or mechanical thrombectomy
  • Failure/inability/unwillingness to provide informed consent
  • The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted primary PCI treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

Other trials in United States

About this study

Official title: An Evaluation of Performance of the CorPath® GRX System in Robotic-PCI During Acute STEMI

This study will evaluate the performance of the CorPath GRX System in Robotic Primary PCI (RPPCI) in the treatment of ST-elevated myocardial infarction (STEMI).

Read the detailed description

This is a prospective, post-market, single-arm, multi-center, observational study to evaluate the performance of the CorPath GRX System during robotic-PCI for acute ST elevation myocardial infarction (STEMI).

Being tested
Robotic-PCI (CorPath GRX System)
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robotic-PCI (CorPath GRX System)Device

    Robotic-PCI for acute ST elevation myocardial infarction (STEMI).

Study groups in NCT04459299
Study groupRoleWhat they receive
STEMI patients with clinical indication for primary PCISubjects with a clinical indication of STEMI.
Receives: Device: Robotic-PCI (CorPath GRX System)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from Catheterization Lab Arrival to Device Activation (CLADA) by CorPath GRX System.

    Time measured from arrival to Cath Lab to device activation by CorPath GRX System.

    Measured: Procedure

Secondary outcomes (11)

  1. Freedom from MACE events

    Completion of the STEMI procedure without in-hospital major adverse cardiovascular event MACE). MACE is defined as cardiac death, clinically driven target vessel revascularization (TVR) by repeat PCI, surgical bypass for any segment of the target vessel or stent thrombosis.

    Measured: 72-hours

  2. First Medical Contact (FMC) to device activation time

    Time at which first patient evaluation.

    Measured: Procedure

  3. Access to device activation

    Time measured from access sheath insertion to device activation by CorPath GRX System.

    Measured: Procedure

  4. Access to wire time

    Defined as time measured from sheath insertion to crossing the lesion with the coronary guidewire.

    Measured: Procedure

  5. Overall procedure time

    Defined as the time measured from sheath insertion to removal of the last device used to treat the culprit lesion.

    Measured: Procedure

  6. Fluoroscopy time

    Total fluoroscopy time (min.) utilized during the procedure as recorded by the Imaging System.

    Measured: Procedure

  7. Patient radiation exposure

    DAP (dose-area-product) and AK (air kerma) as recorded during the procedure.

    Measured: Procedure

  8. Contrast fluid volume

    Total contrast volume (mL/cc) used during the procedure.

    Measured: Procedure

  9. Conversion to manual (Binary)

    Conversion from robotic technique to manual technique due to inability to successfully wire lesion or deliver first device.

    Measured: Procedure

  10. Technical success

    Completion of the PCI procedure entirely robotically or with partial manual assistance.

    Measured: Procedure

  11. Serious adverse events

    All Serious Adverse Events (SAEs) from the start of the CorPath GRX procedure until the end of the study will be summarized.

    Measured: 72-hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start28 Sep 2020
  3. Primary completion26 Nov 2020
  4. Study completion29 Nov 2020

Why it stopped: Low enrollment and sponsor business decision

Resources

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04459299
Sponsor's protocol ID
104-09062
Acronym
TREAT GRX
Status last verified
Jan 2022
First submitted
1 Jul 2020
Last updated
20 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: Data will be available 12 months after study completion.

Publications

  • Hirshfeld JW Jr, Balter S, Brinker JA, Kern MJ, Klein LW, Lindsay BD, Tommaso CL, Tracy CM, Wagner LK, Creager MA, Elnicki M, Lorell BH, Rodgers GP, Weitz HH; American College of Cardiology Foundation; American Heart Association/; HRS; SCAI; American College of Physicians Task Force on Clinical Competence and Training. ACCF/AHA/HRS/SCAI clinical competence statement on physician knowledge to optimize patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures: a report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training. Circulation. 2005 Feb 1;111(4):511-32. doi: 10.1161/01.CIR.0000157946.29224.5D. No abstract available.

    PubMed 15687141

  • Klein LW, Miller DL, Balter S, Laskey W, Haines D, Norbash A, Mauro MA, Goldstein JA; Joint Inter-Society Task Force on Occupational Hazards in the Interventional Laboratory. Occupational health hazards in the interventional laboratory: time for a safer environment. Catheter Cardiovasc Interv. 2009 Feb 15;73(3):432-8. doi: 10.1002/ccd.21801.

    PubMed 19214981

  • Miller DL, Schueler BA, Balter S; National Council on Radiation Protection and Measurements; International Commission on Radiological Protection. New recommendations for occupational radiation protection. J Am Coll Radiol. 2012 May;9(5):366-8. doi: 10.1016/j.jacr.2012.02.006. No abstract available.

    PubMed 22554637

  • Ciraj-Bjelac O, Rehani MM, Sim KH, Liew HB, Vano E, Kleiman NJ. Risk for radiation-induced cataract for staff in interventional cardiology: is there reason for concern? Catheter Cardiovasc Interv. 2010 Nov 15;76(6):826-34. doi: 10.1002/ccd.22670.

    PubMed 20549683

  • Vano E, Kleiman NJ, Duran A, Romano-Miller M, Rehani MM. Radiation-associated lens opacities in catheterization personnel: results of a survey and direct assessments. J Vasc Interv Radiol. 2013 Feb;24(2):197-204. doi: 10.1016/j.jvir.2012.10.016. Epub 2013 Jan 28.

    PubMed 23369556

  • Mahmud E, Naghi J, Ang L, Harrison J, Behnamfar O, Pourdjabbar A, Reeves R, Patel M. Demonstration of the Safety and Feasibility of Robotically Assisted Percutaneous Coronary Intervention in Complex Coronary Lesions: Results of the CORA-PCI Study (Complex Robotically Assisted Percutaneous Coronary Intervention). JACC Cardiovasc Interv. 2017 Jul 10;10(13):1320-1327. doi: 10.1016/j.jcin.2017.03.050.

    PubMed 28683937

Questions about this trial

What is this clinical trial studying?

An observational study of STEMI - ST Elevation Myocardial Infarction and CAD, run by Siemens Healthineers Endovascular Robotics, Inc. at 1 site in United States.

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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 was stopped early (reason given: Low enrollment and sponsor business decision). Results are not available in the source record.

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?

Time from Catheterization Lab Arrival to Device Activation (CLADA) by CorPath GRX System. (time frame: Procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04459299, which also lists 6 linked publications.

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 20 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.

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