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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.

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Chronic Total Occlusion of Coronary Artery Percutaneous Coronary Intervention Device: Robotic CTO PCI Procedure: Conventional (Manual) CTO PCI

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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Cath Lab Staff Radiation Exposure During Chronic Total Occlusion PCI: CorPath GRX vs. Manual
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Device: Robotic CTO PCI
Randomized to robotic CTO PCI.
Other Name: CorPath GRX System

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.
Procedure: Conventional (Manual) CTO PCI
Randomized to manual CTO PCI.




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. Operator Radiation Exposure [ Time Frame: Procedure ]
    Cumulative dose the physician receives as recorded from electronic pocket dosimeter during procedure.

  2. Staff Radiation Exposure [ Time Frame: Procedure ]
    Cumulative dose the staff receives as recorded from electronic pocket dosemeter during procedure.

  3. Patient Radiation Exposure [ Time Frame: Procedure ]
    DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure

  4. Fluoroscopy Time [ Time Frame: Procedure ]
    Total fluoroscopy (min.) utilized during the procedure as recorded by an Imaging System.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959072


Contacts
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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

Locations
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United States, Pennsylvania
WellSpan York Hospital Not yet recruiting
York, Pennsylvania, United States, 17405
Contact: Elayne Grimm    717-851-3264    egrim@wellspan.org   
Principal Investigator: William J Nicholson, MD         
Sponsors and Collaborators
Corindus Inc.
Investigators
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Principal Investigator: William Nicholson, MD WellSpan York Hospital
  Study Documents (Full-Text)

Documents provided by Corindus Inc.:
Study Protocol  [PDF] April 4, 2019


Publications:

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Responsible Party: Corindus Inc.
ClinicalTrials.gov Identifier: NCT03959072     History of Changes
Other Study ID Numbers: 104-08553
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be available 12 months after study completion.

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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
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases