Cardiac Cath Lab Staff Radiation Exposure

Terminated

• Conditions: Chronic Total Occlusion of Coronary Artery; Percutaneous Coronary Intervention; Coronary Artery Disease
• Interventions: Device: Robotic CTO PCI; Procedure: Conventional (Manual) CTO PCI

• Registration Number: NCT03959072
• Lead Sponsor: Corindus Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-22
• Study Start: 2019-09-05
• Primary Completion: 2021-09-14
• Study Completion: 2021-09-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 74

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robotic Chronic Total Occlusion PCI	Robotic CTO 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) Chronic Total Occlusion PCI	Conventional (Manual) CTO 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.

Primary Outcome Measures

Name	Time	Method
Clinical Success	48 hours	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).
In-hospital Major Adverse Events (MAE)	48 hours	Number of MAE events that occurs within 48 hours of the CTO PCI procedure or hospital discharge, whichever occurs first.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University of Washington; 🇺🇸 Seattle, Washington, United States

St. Luke's Hospital of Kansas City; 🇺🇸 Kansas City, Missouri, United States

WellSpan York Hospital; 🇺🇸 York, Pennsylvania, United States