Cardiac Cath Lab Staff Radiation Exposure (SAFE-T)

Corindus

Status: Terminated

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Chronic Total Occlusion of Coronary Artery

Treatments: Device: Robotic CTO PCI; Procedure: Conventional (Manual) CTO PCI

Study type: Observational

Funder types: Industry

Identifiers

NCT03959072

104-08553

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

74 participants in 2 patient groups

Robotic Chronic Total Occlusion PCI

Description:

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.

Treatment:

Device: Robotic CTO PCI

Conventional (manual) Chronic Total Occlusion PCI

Description:

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.

Treatment:

Procedure: Conventional (Manual) CTO PCI