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Cardiac Cath Lab Staff Radiation Exposure (SAFE-T)

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ClinicalTrials.gov Identifier: NCT03959072
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Corindus Inc.

Tracking Information
First Submitted Date May 20, 2019
First Posted Date May 22, 2019
Last Update Posted Date August 15, 2019
Estimated Study Start Date September 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2019)
  • Clinical Success [ Time Frame: 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) [ Time Frame: 48 hours ]
    Number of MAE events that occurs within 48 hours of the CTO PCI procedure or hospital discharge, whichever occurs first.
Original Primary Outcome Measures
 (submitted: May 20, 2019)
  • Clinical Success [ Time Frame: 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) [ Time Frame: 48 hours ]
    MAE that occurs within 48 hours of the CTO PCI procedure or hospital discharge, whichever occurs first.
Change History Complete list of historical versions of study NCT03959072 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 20, 2019)
  • Operator Radiation Exposure [ Time Frame: Procedure ]
    Cumulative dose the physician receives as recorded from electronic pocket dosimeter during procedure.
  • Staff Radiation Exposure [ Time Frame: Procedure ]
    Cumulative dose the staff receives as recorded from electronic pocket dosemeter during procedure.
  • Patient Radiation Exposure [ Time Frame: Procedure ]
    DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure
  • Fluoroscopy Time [ Time Frame: Procedure ]
    Total fluoroscopy (min.) utilized during the procedure as recorded by an Imaging System.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiac Cath Lab Staff Radiation Exposure
Official Title Cardiac Cath Lab Staff Radiation Exposure During Chronic Total Occlusion PCI: CorPath GRX vs. Manual
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Subjects >18 years of age with symptoms suggestive of ischemic heart disease, with TIMI grade 0 flow and a lesion that is thought to be present for more than 3 months.
Condition
  • Coronary Artery Disease
  • Chronic Total Occlusion of Coronary Artery
  • Percutaneous Coronary Intervention
Intervention
  • Device: Robotic CTO PCI
    Randomized to robotic CTO PCI.
    Other Name: CorPath GRX System
  • Procedure: Conventional (Manual) CTO PCI
    Randomized to manual CTO PCI.
Study Groups/Cohorts
  • 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.
    Intervention: Device: 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.
    Intervention: Procedure: Conventional (Manual) CTO PCI
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 20, 2019)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Tina M. Ridgeway, BS, RN (757) 810-5166 tina.ridgeway@corindus.com
Contact: John Van Vleet, MS (260) 615-8892 john.vanvleet@corindus.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03959072
Other Study ID Numbers 104-08553
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Data will be available 12 months after study completion.
Responsible Party Corindus Inc.
Study Sponsor Corindus Inc.
Collaborators Not Provided
Investigators
Principal Investigator: William Nicholson, MD WellSpan York Hospital
PRS Account Corindus Inc.
Verification Date May 2019