TerminatedNCT03959072SAFE-TUpdated Feb 2, 2023

Cardiac Cath Lab Staff Radiation Exposure

An observational study in Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery and Percutaneous Coronary Intervention, sponsored by Corindus Inc.. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-02.

Sponsored by Corindus Inc. · Observational

Why this study was terminated

Sponsor decision due to lower than anticipated enrollment

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 74
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

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

Browse trials for

Coronary Artery Disease 5,581

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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.

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

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 design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 74 participants (actual)
Patient registry: No

Groups and cohorts

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

DeviceRobotic CTO PCI
Randomized to robotic CTO PCI.
Also known as: CorPath GRX System
ProcedureConventional (Manual) CTO PCI
Randomized to manual CTO PCI.

What researchers measure

Primary outcomes

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).
Time frame: 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.
Time frame: 48 hours

Secondary outcomes

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

Study locations

3 sites

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

References and documents

Publications

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. PubMed 15687141 ↗
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. PubMed 19214981 ↗
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. PubMed 22554637 ↗
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. PubMed 20549683 ↗
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. PubMed 23369556 ↗
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. PubMed 28683937 ↗

Study documents

Study protocol · Feb 8, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — Data will be available 12 months after study completion.

Registry details

Key details

Study ID: NCT03959072
Lead sponsor: Corindus Inc.
Responsible party: Sponsor
First posted: May 22, 2019
Start date: Sep 5, 2019
Primary completion: Sep 14, 2021
Completion: Sep 15, 2021
Last update: Feb 2, 2023

Study contacts

William Lombardi (Acting), MD

principal investigator · University of Washington

William Nicholson (Emeritus), MD

principal investigator · WellSpan York Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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