Cardiac Cath Lab Staff Radiation Exposure

NCT03959072 | Terminated FDA Device

• 1 other identifier: 104-08553
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Operator Radiation Exposure

  Procedure

• Staff Radiation Exposure

  Procedure

• Patient Radiation Exposure

  Procedure

• Fluoroscopy Time

  Procedure

Study Arms (2)

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

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

Interventions

Robotic CTO PCI DEVICE

Randomized to robotic CTO PCI.

Also known as: CorPath GRX System

Robotic Chronic Total Occlusion PCI

Conventional (Manual) CTO PCI PROCEDURE

Randomized to manual CTO PCI.

Conventional (manual) Chronic Total Occlusion PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Corindus Inc.: lead

Study Sites (3)

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

WellSpan York Hospital

York, Pennsylvania, 17405, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (6)

• 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.

  PMID: 15687141 BACKGROUND

• 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.

  PMID: 19214981 BACKGROUND

• 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.

  PMID: 22554637 BACKGROUND

• 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.

  PMID: 20549683 BACKGROUND

• 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.

  PMID: 23369556 BACKGROUND

• 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.

  PMID: 28683937 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• William Lombardi (Acting), MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• William Nicholson (Emeritus), MD

  WellSpan York Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: September 5, 2019
• Primary Completion: September 14, 2021
• Study Completion: September 15, 2021
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

US (3)