Cardiac Cath Lab Staff Radiation Exposure During Chronic Total Occlusion PCI: CorPath GRX vs. Manual
Status: Terminated
Location: See all (3) locations...
Intervention Type: Procedure, Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:
• 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.
Locations
United States
Missouri
St. Luke's Hospital of Kansas City
Kansas City
Pennsylvania
WellSpan York Hospital
York
Washington
University of Washington
Seattle
Time Frame
Start Date: 2019-09-05
Completion Date: 2021-09-15
Participants
Target number of participants: 74
Treatments
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.
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.
Authors
William Lombardi, Adam Salisbury, William J Nicholson
Related Therapeutic Areas
Sponsors
Leads: Corindus Inc.