Cardiac Cath Lab Staff Radiation Exposure (SAFE-T)

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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Chronic Total Occlusion of Coronary Artery
• Intervention / Treatment: Device: Robotic CTO PCI; Procedure: Conventional (Manual) CTO PCI

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital of Kansas City
  • Pennsylvania
    • York, Pennsylvania, United States, 17405
      • WellSpan York Hospital
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects >18 years of age with symptoms suggestive of ischemic heart disease, with TIMI grade 0 flow and a lesion that is thought to be present for more than 3 months.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Robotic Chronic Total Occlusion PCI; The procedure will be randomized in a 1:1 fashion to either CorPath GRX robotic-assisted Chronic Total Occlusion PCI or conventional manual Chronic Total Occlusion PCI.	Device: Robotic CTO PCI; Randomized to robotic CTO PCI.; Other Names: CorPath GRX System
Conventional (manual) Chronic Total Occlusion PCI; The procedure will be randomized in a 1:1 fashion to either CorPath GRX robotic-assisted Chronic Total Occlusion PCI or conventional manual Chronic Total Occlusion PCI.	Procedure: Conventional (Manual) CTO PCI; Randomized to manual CTO PCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operator Radiation Exposure	Cumulative dose the physician receives as recorded from electronic pocket dosimeter during procedure.	Procedure
Staff Radiation Exposure	Cumulative dose the staff receives as recorded from electronic pocket dosemeter during procedure.	Procedure
Patient Radiation Exposure	DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure	Procedure
Fluoroscopy Time	Total fluoroscopy (min.) utilized during the procedure as recorded by an Imaging System.	Procedure

Collaborators and Investigators

• Sponsor: Corindus Inc.
• Investigators: Principal Investigator: William Lombardi (Acting), MD, University of Washington; Principal Investigator: William Nicholson (Emeritus), MD, WellSpan York Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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 5, 2019
• Primary Completion (ACTUAL): September 14, 2021
• Study Completion (ACTUAL): September 15, 2021

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (ACTUAL): May 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 104-08553

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