ClinicalTrials.gg
TerminatedNCT04459299TREAT GRXUpdated Dec 20, 2023

CorPath GRX STEMI Study

An observational study in STEMI - ST Elevation Myocardial Infarction and CAD, sponsored by Corindus Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-20.

Sponsored by Corindus Inc. (part of Siemens Healthineers) · Observational

Why this study was terminated
Low enrollment and sponsor business decision
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 82 studies in ST Elevation Myocardial Infarction with a site in United States — 5 open to participants now, 11 under way, 1 of them phase 3. ST Elevation Myocardial Infarction · United States.

Enrollment
26th of 27
3 · median 324
Started
2020
with 4 others
Observational
27 of 82
3 open now
Registered
60th of 82
by date

Among the 82 studies in ST Elevation Myocardial Infarction with a site in United States, this one is the 26th largest by enrollment of the 27 observational ones that give a count, is one of 5 that started in 2020, is one of 27 observational ones, and was the 60th registered.

ST Elevation Myocardial Infarction

851 studies on the registry are indexed under ST Elevation Myocardial Infarction; 198 are open to participants now.

Browse ST Elevation Myocardial Infarction studies →

Open to participants now

5 of the 82 studies in ST Elevation Myocardial Infarction with a site in United States are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 122 ST Elevation Myocardial Infarction studies recruiting now, 76 (62%) set no upper age limit and 20 (16%) stop at 75 or younger; 10 take children under 18; 9 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 82 studies in ST Elevation Myocardial Infarction with a site in United States, or all of them as a file.
02

Study 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 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).

03

Conditions studied

  • STEMI - ST Elevation Myocardial Infarction
  • CAD
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects with a clinical indication of STEMI.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

Cardiogenic shock

  • Cardiac arrest
  • Need for manual or mechanical thrombectomy
  • Failure/inability/unwillingness to provide
  • The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted primary PCI treatment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3 participants (actual)
Patient registry
No

Groups and cohorts

  • STEMI patients with clinical indication for primary PCI

    Subjects with a clinical indication of STEMI.

    Device: Robotic-PCI (CorPath GRX System)

Interventions

  • DeviceRobotic-PCI (CorPath GRX System)

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: Procedure

Secondary outcomes

  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.

    Time frame: 72-hours

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

    Time at which first patient evaluation.

    Time frame: Procedure

  3. Access to device activation

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

    Time frame: Procedure

  4. Access to wire time

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

    Time frame: 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.

    Time frame: Procedure

  6. Fluoroscopy time

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

    Time frame: Procedure

  7. Patient radiation exposure

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

    Time frame: Procedure

  8. Contrast fluid volume

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

    Time frame: Procedure

  9. Conversion to manual (Binary)

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

    Time frame: Procedure

  10. Technical success

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

    Time frame: 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.

    Time frame: 72-hours

07

Study locations

1 site
  • Wellstar Kennestone Hospital
    Marietta, Georgia 30060, United States
08

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — Data will be available 12 months after study completion.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2020 to primary completion in Nov 2020, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2020
First posted
Jul 7, 2020
StartActual
Sep 28, 2020
Primary completionActual
Nov 26, 2020
CompletionActual
Nov 29, 2020
Last update
Dec 20, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04459299
Lead sponsor
Corindus Inc.
Responsible party
Sponsor
First posted
Jul 7, 2020
Start date
Sep 28, 2020
Primary completion
Nov 26, 2020
Completion
Nov 29, 2020
Last update
Dec 20, 2023

Study contacts

Salvatore F Mannino, DO, MA
study chair · WellStar Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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