Cardiac Cath Lab Staff Radiation Exposure

Coronary Artery Disease Clinical Trial

— SAFE-T  

Official title:

Cardiac Cath Lab Staff Radiation Exposure During Chronic Total Occlusion PCI: CorPath GRX vs. Manual

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03959072
• Other study ID #: 104-08553
• Status: Terminated
• Start date: September 5, 2019
• Est. completion date: September 15, 2021

Study information

• Verified date: January 2023
• Source: Corindus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this randomized safety and observational study is to demonstrate CorPath GRX chronic total occlusion PCI is safe, and that Cardiac Catheterization Laboratory staff have no additional exposure to radiation when compared to conventional manual chronic total occlusion PCI procedures without added procedure time.

Description:

This is prospective, dual-arm, randomized, multi-center, observational study comparing patient outcomes and staff radiation exposure in chronic total occlusion PCI procedures through 48 hours post procedure or hospital discharge, whichever occurs first.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: September 15, 2021
• Est. primary completion date: September 14, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CTO lesion, successfully crossed with conventional manual techniques;
• The Investigator deems the procedure appropriate for robotic-assisted CTO PCI with the CorPath GRX System;
• Individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure;
• The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

• Failure/inability/unwillingness to provide informed consent, or
• Cardiogenic Shock; or
• Perforation which requires treatment (e.g. covered stent, coil and other embolization techniques, or pericardiocentesis).

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery
• Coronary Artery Disease
• Percutaneous Coronary Intervention

Intervention

Device:
• Robotic CTO PCI
Randomized to robotic CTO PCI.

Procedure:
• Conventional (Manual) CTO PCI
Randomized to manual CTO PCI.

Locations

Country	Name	City	State
United States	St. Luke's Hospital of Kansas City	Kansas City	Missouri
United States	University of Washington	Seattle	Washington
United States	WellSpan York Hospital	York	Pennsylvania

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	Clinical Success	Defined as successful CTO PCI revascularization with achievement of <30% residual diameter stenosis (visual estimate) within the treated segment and restoration of antegrade TIMI grade 3 flow, without in-hospital major adverse events (MAE).	48 hours
Primary	In-hospital Major Adverse Events (MAE)	Number of MAE events that occurs within 48 hours of the CTO PCI procedure or hospital discharge, whichever occurs first.	48 hours
Secondary	Operator Radiation Exposure	Cumulative dose the physician receives as recorded from electronic pocket dosimeter during procedure.	Procedure
Secondary	Staff Radiation Exposure	Cumulative dose the staff receives as recorded from electronic pocket dosemeter during procedure.	Procedure
Secondary	Patient Radiation Exposure	DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure	Procedure
Secondary	Fluoroscopy Time	Total fluoroscopy (min.) utilized during the procedure as recorded by an Imaging System.	Procedure