Cardiac Cath Lab Staff Radiation Exposure

Corindus Inc.74 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Robotic CTO PCIDEVICE

Randomized to robotic CTO PCI.

Conventional (Manual) CTO PCIPROCEDURE

Randomized to manual CTO PCI.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (3)

St. Luke's Hospital of Kansas City

Kansas City, Missouri, United States

WellSpan York Hospital

York, Pennsylvania, United States

University of Washington

Seattle, Washington, United States

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: 48 hours

Secondary Outcomes

Operator Radiation Exposure

Cumulative dose the physician receives as recorded from electronic pocket dosimeter during procedure.

Time frame: Procedure

Staff Radiation Exposure

Cumulative dose the staff receives as recorded from electronic pocket dosemeter during procedure.

Time frame: Procedure

Patient Radiation Exposure

DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure

Time frame: Procedure

Fluoroscopy Time

Total fluoroscopy (min.) utilized during the procedure as recorded by an Imaging System.

Time frame: Procedure

Data from ClinicalTrials.gov

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