Cardiac Cath Lab Staff Radiation Exposure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-05

Study Completion Date

2021-09-15

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Robotic CTO PCI

Intervention Type DEVICE

Randomized to robotic CTO 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.

Conventional (Manual) CTO PCI

Intervention Type PROCEDURE

Randomized to manual CTO PCI.

Interventions

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Robotic CTO PCI

Randomized to robotic CTO PCI.

Intervention Type DEVICE

Conventional (Manual) CTO PCI

Randomized to manual CTO PCI.

Intervention Type PROCEDURE

Other Intervention Names

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CorPath GRX System

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No