CorPath GRX STEMI Study (TREAT GRX)

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).

Study Overview

• Status: Terminated
• Conditions: CAD; STEMI - ST Elevation Myocardial Infarction
• Intervention / Treatment: Device: Robotic-PCI (CorPath GRX System)

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).

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Wellstar Kennestone Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with a clinical indication of STEMI.

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
STEMI patients with clinical indication for primary PCI; Subjects with a clinical indication of STEMI.	Device: Robotic-PCI (CorPath GRX System); Robotic-PCI for acute ST elevation myocardial infarction (STEMI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72-hours
First Medical Contact (FMC) to device activation time	Time at which first patient evaluation.	Procedure
Access to device activation	Time measured from access sheath insertion to device activation by CorPath GRX System.	Procedure
Access to wire time	Defined as time measured from sheath insertion to crossing the lesion with the coronary guidewire.	Procedure
Overall procedure time	Defined as the time measured from sheath insertion to removal of the last device used to treat the culprit lesion.	Procedure
Fluoroscopy time	Total fluoroscopy time (min.) utilized during the procedure as recorded by the Imaging System.	Procedure
Patient radiation exposure	DAP (dose-area-product) and AK (air kerma) as recorded during the procedure.	Procedure
Contrast fluid volume	Total contrast volume (mL/cc) used during the procedure.	Procedure
Conversion to manual (Binary)	Conversion from robotic technique to manual technique due to inability to successfully wire lesion or deliver first device.	Procedure
Technical success	Completion of the PCI procedure entirely robotically or with partial manual assistance.	Procedure
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.	72-hours

Collaborators and Investigators

• Sponsor: Corindus Inc.
• Investigators: Study Chair: Salvatore F Mannino, DO, MA, Wellstar Health System

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Actual): November 26, 2020
• Study Completion (Actual): November 29, 2020

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 104-09062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be available 12 months after study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No