NCT03959072

Cardiac Cath Lab Staff Radiation Exposure

Cardiac Cath Lab Staff Radiation Exposure During Chronic Total Occlusion PCI: CorPath GRX vs. Manual

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: Corindus Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Robotic CTO PCI	Randomized to robotic CTO PCI.
PROCEDURE	Conventional (Manual) CTO PCI	Randomized to manual CTO PCI.

Timeline

• Start date: 2019-09-05
• Primary completion: 2021-09-14
• Completion: 2021-09-15
• First posted: 2019-05-22
• Last updated: 2023-02-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study