Cardiac Cath Lab Staff Radiation Exposure

Stopped early

Conditions studied: Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Percutaneous Coronary Intervention

In brief

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.

Key facts

Study ID

NCT03959072

Run by

Siemens Healthineers Endovascular Robotics, Inc.

People needed

74

Starts

2019-09-05

Expected to finish

2021-09-15

Last updated by the study team

2023-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• St. Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• WellSpan York Hospital — York, Pennsylvania, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.