Cardiac Cath Lab Staff Radiation Exposure (SAFE-T)
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ClinicalTrials.gov Identifier: NCT03959072 |
Recruitment Status :
Recruiting
First Posted : May 22, 2019
Last Update Posted : January 8, 2021
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Condition or disease | Intervention/treatment |
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Coronary Artery Disease Chronic Total Occlusion of Coronary Artery Percutaneous Coronary Intervention | Device: Robotic CTO PCI Procedure: Conventional (Manual) CTO PCI |
Study Type : | Observational |
Estimated Enrollment : | 90 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Cardiac Cath Lab Staff Radiation Exposure During Chronic Total Occlusion PCI: CorPath GRX vs. Manual |
Actual Study Start Date : | September 5, 2019 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | July 2021 |

Group/Cohort | 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.
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Device: Robotic CTO PCI
Randomized to robotic CTO PCI.
Other Name: CorPath GRX System |
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.
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Procedure: Conventional (Manual) CTO PCI
Randomized to manual CTO PCI. |
- Clinical Success [ Time Frame: 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) [ Time Frame: 48 hours ]Number of MAE events that occurs within 48 hours of the CTO PCI procedure or hospital discharge, whichever occurs first.
- Operator Radiation Exposure [ Time Frame: Procedure ]Cumulative dose the physician receives as recorded from electronic pocket dosimeter during procedure.
- Staff Radiation Exposure [ Time Frame: Procedure ]Cumulative dose the staff receives as recorded from electronic pocket dosemeter during procedure.
- Patient Radiation Exposure [ Time Frame: Procedure ]DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure
- Fluoroscopy Time [ Time Frame: Procedure ]Total fluoroscopy (min.) utilized during the procedure as recorded by an Imaging System.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Probability Sample |
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:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959072
Contact: Tina M. Ridgeway, BS, RN | (757) 810-5166 | tina.ridgeway@corindus.com | |
Contact: John Van Vleet, MS | (260) 615-8892 | john.vanvleet@corindus.com |
United States, Missouri | |
St. Luke's Hospital of Kansas City | Recruiting |
Kansas City, Missouri, United States, 64111 | |
Contact: Rosann Gans, RN 816-932-6122 rgans@saint-lukes.org | |
Principal Investigator: Adam Salisbury, MD | |
United States, Pennsylvania | |
WellSpan York Hospital | Completed |
York, Pennsylvania, United States, 17405 | |
United States, Washington | |
University of Washington | Not yet recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Kamilah Taylor 206-221-2142 kit2@cardiology.washington.edu | |
Principal Investigator: William Lombardi, MD |
Principal Investigator: | William Lombardi (Acting), MD | University of Washington | |
Principal Investigator: | William Nicholson (Emeritus), MD | WellSpan York Hospital |
Responsible Party: | Corindus Inc. |
ClinicalTrials.gov Identifier: | NCT03959072 |
Other Study ID Numbers: |
104-08553 |
First Posted: | May 22, 2019 Key Record Dates |
Last Update Posted: | January 8, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Data will be available 12 months after study completion. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |