Cardiac Cath Lab Staff Radiation Exposure
NCT03959072 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 74
Last updated 2023-02-02
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.
Conditions
- Coronary Artery Disease
- Chronic Total Occlusion of Coronary Artery
- Percutaneous Coronary Intervention
Interventions
- DEVICE
-
Robotic CTO PCI
Randomized to robotic CTO PCI.
- PROCEDURE
-
Conventional (Manual) CTO PCI
Randomized to manual CTO PCI.
Sponsors & Collaborators
-
Corindus Inc.
lead INDUSTRY
Principal Investigators
-
William Lombardi (Acting), MD · University of Washington
-
William Nicholson (Emeritus), MD · WellSpan York Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-05
- Primary Completion
- 2021-09-14
- Completion
- 2021-09-15
- FDA Device
- Yes
Countries
- United States
Study Locations
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