SAFE-T: Cardiac Cath Lab Staff Radiation Exposure
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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:
|
| 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.
|
Outcome Measures
Primary Outcome Measures
- Clinical Success [48 hours]
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).
- In-hospital Major Adverse Events (MAE) [48 hours]
Number of MAE events that occurs within 48 hours of the CTO PCI procedure or hospital discharge, whichever occurs first.
Secondary Outcome Measures
- Operator Radiation Exposure [Procedure]
Cumulative dose the physician receives as recorded from electronic pocket dosimeter during procedure.
- Staff Radiation Exposure [Procedure]
Cumulative dose the staff receives as recorded from electronic pocket dosemeter during procedure.
- Patient Radiation Exposure [Procedure]
DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure
- Fluoroscopy Time [Procedure]
Total fluoroscopy (min.) utilized during the procedure as recorded by an Imaging System.
Eligibility Criteria
Criteria
Inclusion Criteria:
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CTO lesion, successfully crossed with conventional manual techniques;
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The Investigator deems the procedure appropriate for robotic-assisted CTO PCI with the CorPath GRX System;
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Individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure;
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The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria:
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Failure/inability/unwillingness to provide informed consent, or
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Cardiogenic Shock; or
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Perforation which requires treatment (e.g. covered stent, coil and other embolization techniques, or pericardiocentesis).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Luke's Hospital of Kansas City | Kansas City | Missouri | United States | 64111 |
| 2 | WellSpan York Hospital | York | Pennsylvania | United States | 17405 |
| 3 | University of Washington | Seattle | Washington | United States | 98195 |
Sponsors and Collaborators
- Corindus Inc.
Investigators
- Principal Investigator: William Lombardi (Acting), MD, University of Washington
- Principal Investigator: William Nicholson (Emeritus), MD, WellSpan York Hospital
Study Documents (Full-Text)
More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 104-08553