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

September 21, 2020 updated by: Kongteng Tan, University Health Network, Toronto

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • University Health Network
        • Contact:
          • Kong Teng Tan, MD
          • Phone Number: 416 340-3111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 30 days
Infection, bleeding, stroke, pseudoaneurysm formation, etc.
30 days
All cause mortality
Time Frame: 30 days
Post procedural death.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke
Time Frame: 7 days
Physical examination and magnetic resonance imaging (MRI) brain.
7 days
Silent Infarction
Time Frame: 7 days
MRI brain.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 20, 2019

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

March 31, 2021

Study Registration Dates

First Submitted

June 24, 2019

First Submitted That Met QC Criteria

June 24, 2019

First Posted (ACTUAL)

June 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-5219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share data with other researchers.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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