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Cardiac Cath Lab Staff Radiation Exposure | Clinical Trials | Clareo Health

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TERMINATEDNCT03959072

Cardiac Cath Lab Staff Radiation Exposure

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 ...

Lead sponsor: Siemens Healthineers Endovascular Robotics, Inc.•3 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Siemens Healthineers Endovascular Robotics, Inc.

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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).

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 2, 2023Terms

Trial snapshot

StatusTERMINATED

Phase—

Enrollment74

Start dateSep 2019

Last updatedFeb 2, 2023

Condition

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

Locations shown

St. Luke's Hospital of Kansas City

Kansas City, Missouri

WellSpan York Hospital

York, Pennsylvania

University of Washington

Seattle, Washington

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2023Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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