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Coronary Artery DiseaseSAFE-TNCT03959072

Cardiac Cath Lab Staff Radiation Exposure

An observational study of Coronary Artery Disease and Chronic Total Occlusion of Coronary Artery, run by Siemens Healthineers Endovascular Robotics, Inc. at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Robotic CTO PCI and Conventional (Manual) CTO PCI
How many people
74 participants
Where
3 sitesUnited States
Study dates
5 Sep 2019to 15 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • University of Washington

    Seattle, Washington, 98195

  • WellSpan York Hospital

    York, Pennsylvania, 17405

Other trials in United States

About this study

Official title: 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.

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.

Being tested
Robotic CTO PCI, Conventional (Manual) CTO PCI
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robotic CTO PCIDevice

    Also called CorPath GRX System

    Randomized to robotic CTO PCI.

  • Conventional (Manual) CTO PCIProcedure or surgery

    Randomized to manual CTO PCI.

Study groups in NCT03959072
Study groupRoleWhat they receive
Robotic Chronic Total Occlusion PCIThe 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.
Receives: Device: Robotic CTO PCI
Conventional (manual) Chronic Total Occlusion PCIThe 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.
Receives: Procedure: Conventional (Manual) CTO PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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.

    Measured: 48 hours

Secondary outcomes (4)

  1. Operator Radiation Exposure

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

    Measured: Procedure

  2. Staff Radiation Exposure

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

    Measured: Procedure

  3. Patient Radiation Exposure

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

    Measured: Procedure

  4. Fluoroscopy Time

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

    Measured: Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2019
  2. Study start5 Sep 2019
  3. Primary completion14 Sep 2021
  4. Study completion15 Sep 2021

Why it stopped: Sponsor decision due to lower than anticipated enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03959072
Sponsor's protocol ID
104-08553
Acronym
SAFE-T
Status last verified
Jan 2023
First submitted
20 May 2019
Last updated
2 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: Data will be available 12 months after study completion.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Chronic Total Occlusion of Coronary Artery, run by Siemens Healthineers Endovascular Robotics, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision due to lower than anticipated enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Success (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03959072, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.

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Cardiac Cath Lab Staff Radiation Exposure | AzTrials