CorPath GRX STEMI Study

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— TREAT GRX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04459299
• Other study ID #: 104-09062
• Status: Terminated
• Start date: September 28, 2020
• Est. completion date: November 29, 2020

Study information

• Verified date: January 2022
• Source: Corindus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 29, 2020
• Est. primary completion date: November 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• CAD
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

Device:
• Robotic-PCI (CorPath GRX System)
Robotic-PCI for acute ST elevation myocardial infarction (STEMI).

Locations

Country	Name	City	State
United States	Wellstar Kennestone Hospital	Marietta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Corindus Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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