Cardiac Cath Lab Staff Radiation Exposure

Study Overview
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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.

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.

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

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

Intervention / Treatment
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* Device: Robotic CTO PCI
* Procedure: Conventional (Manual) CTO PCI


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Robotic Chronic Total Occlusion PCI<br>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. | Device: Robotic CTO PCI<br>* Randomized to robotic CTO PCI.<br>* Other names: CorPath GRX System;|
| Conventional (manual) Chronic Total Occlusion PCI<br>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. | Procedure: Conventional (Manual) CTO PCI<br>* Randomized to manual CTO PCI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success | Defined as successful CTO PCI revascularization with achievement of <30% residual diameter stenosis (visual estimate) within the treated segment and restoration of antegrade TIMI grade 3 flow, without in-hospital major adverse events (MAE). | 48 hours | 
| In-hospital Major Adverse Events (MAE) | Number of MAE events that occurs within 48 hours of the CTO PCI procedure or hospital discharge, whichever occurs first. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operator Radiation Exposure | Cumulative dose the physician receives as recorded from electronic pocket dosimeter during procedure. | Procedure | 
| Staff Radiation Exposure | Cumulative dose the staff receives as recorded from electronic pocket dosemeter during procedure. | Procedure | 
| Patient Radiation Exposure | DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure | Procedure | 
| Fluoroscopy Time | Total fluoroscopy (min.) utilized during the procedure as recorded by an Imaging System. | Procedure |