ClinicalTrials.gg
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. (part of Siemens Healthineers) · 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
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,105 studies in Coronary Artery Disease with a site in United States — 101 open to participants now, 146 under way, 10 of them phase 3. Coronary Artery Disease · United States.

Enrollment
242nd of 357
74 · median 186
Started
2019
with 39 others
Observational
358 of 1,105
34 open now
Registered
877th of 1,105
by date

Among the 1,105 studies in Coronary Artery Disease with a site in United States, this one is the 242nd largest by enrollment of the 357 observational ones that give a count, is one of 40 that started in 2019, is one of 358 observational ones, and was the 877th registered.

Coronary Artery Disease

4,861 studies on the registry are indexed under Coronary Artery Disease; 892 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

101 of the 1,105 studies in Coronary Artery Disease with a site in United States are open now. Recruiting first, the newest first:

96 more — sign in →

All 101 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 588 Coronary Artery Disease studies recruiting now, 403 (69%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.

This study: 18 Years and older · all sexes.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,105 studies in Coronary Artery Disease with a site in United States, or all of them as a file.
02

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.

03

Conditions studied

  • Coronary Artery Disease
  • Chronic Total Occlusion of Coronary Artery
  • Percutaneous Coronary Intervention
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Failure/inability/unwillingness to provide , or
  • Cardiogenic Shock; or
  • Perforation which requires treatment (e.g. covered stent, coil and other embolization techniques, or pericardiocentesis).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. Operator Radiation Exposure

    Cumulative dose the physician receives as recorded from electronic pocket dosimeter during procedure.

    Time frame: Procedure

  2. Staff Radiation Exposure

    Cumulative dose the staff receives as recorded from electronic pocket dosemeter during procedure.

    Time frame: Procedure

  3. Patient Radiation Exposure

    DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure

    Time frame: Procedure

  4. Fluoroscopy Time

    Total fluoroscopy (min.) utilized during the procedure as recorded by an Imaging System.

    Time frame: Procedure

07

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
08

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

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2019 to primary completion in Sep 2021, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2019
First posted
May 22, 2019
StartActual
Sep 5, 2019
Primary completionActual
Sep 14, 2021
CompletionActual
Sep 15, 2021
Last update
Feb 2, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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