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Comparison of Carbon Dioxide and Saline Flush to Saline Flush in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia

Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT03998631
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
20.4
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Thoracic endovascular repair (TEVAR) and transcatheter aortic valve implantation (TAVI) are standard of care procedures to treat thoracic aortic aneurysm or severe aortic stenosis, respectively. Both procedures have a high risk of stroke and silent infarction. Gas has been detected in the cerebral vasculature during these procedures and associated with DWI positive lesions on MRI. The hypothesis is that air emboli contribute to stroke and silent infarction. The investigators propose addressing air emboli by flushing the device with carbon dioxide prior to flushing with saline. This is a pilot study comparing standard saline flush alone to carbon dioxide flushing with saline flush.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Carbon Dioxide and Saline Flush
  • Procedure: Standard Saline Flush
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Carbon Dioxide Flush and Saline Flush to Saline Flush Alone in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia
Actual Study Start Date :
Jul 20, 2019
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Saline Flush

This is the control arm. The TEVAR or TAVI device will be flushed with at least 60mL of standard saline to reduce bubbles in the reservoir prior to deployment. This is the standard of care.

Procedure: Standard Saline Flush
Standard of care flushing of the TEVAR or TAVI device with normal saline.
Other Names:
  • Cook Zenith alpha thoracic endovascular graft
  • Sapien Transcatheter heart valve
  • Core Valve Transcatheter Aortic Valve

    		•
    Experimental: Carbon Dioxide and Saline Flush

    Carbon dioxide flush of the TEVAR or TAVI device followed by saline flush.

    Procedure: Carbon Dioxide and Saline Flush
    The TEVAR or TAVI device will be flushed with approximately 1.2L of medical grade carbon dioxide using a 60mL syringe and connecting tubing. The reservoir will then be flushed with at least 60mL of standard saline prior to deployment to minimize bubbles in the saline.
    Other Names:
  • Cook Zenith alpha thoracic endovascular graft
  • Sapien Transcatheter Heart Valve
  • CoreValve Trascatheter Aortic Valve

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Complications [30 days]

      Infection, bleeding, stroke, pseudoaneurysm formation, etc.

    2. All cause mortality [30 days]

      Post procedural death.

    Secondary Outcome Measures

    1. Stroke [7 days]

      Physical examination and magnetic resonance imaging (MRI) brain.

    2. Silent Infarction [7 days]

      MRI brain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Elective TEVAR or TAVI

    • Over 18 years old

    Exclusion Criteria:

    • Recent acute myocardial infarction

    • Recent stroke or TIA

    • Post or pending organ transplantation

    • Active peptic ulcer disease

    • Recent gastrointestinal bleed

    • History of bleeding diathesis or coagulopathy or contraindications to antiplatelet or anticoagulant therapy.

    • Permanent pacemaker or ICD

    • History of atrial fibrillation

    • Moderate or severe allergy to iodinated contrast not amenable to predmedication

    • Renal failure

    • Unable to safely undergo MRI

    • Enrollment in another study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Network Toronto Ontario Canada M5G 2C4

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Kong Teng Tan, MD, FRCPC, University Health Network, Toronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kongteng Tan, Principal Investigator, University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT03998631
    Other Study ID Numbers:
    • 19-5219
    First Posted:
    Jun 26, 2019
    Last Update Posted:
    Sep 23, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Brain Ischemia
    Cerebral Infarction
    Aneurysm
    Aortic Aneurysm
    Aortic Valve Stenosis
    Aortic Aneurysm, Thoracic
    Ischemia

    Study Results

    No Results Posted as of Sep 23, 2020