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Trial record 23 of 1679 for:    CARBON DIOXIDE AND dioxide

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

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ClinicalTrials.gov Identifier: NCT03998631
Recruitment Status : Not yet recruiting
First Posted : June 26, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Kongteng Tan, University Health Network, Toronto

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. Our hypothesis is that air emboli contribute to stroke and silent infarction. We 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
Thoracic Aortic Aneurysm Aortic Stenosis Symptomatic Stroke, Complication Procedure: Carbon Dioxide and Saline Flush Procedure: Standard Saline Flush Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : December 31, 2020


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




Primary Outcome Measures :
  1. Complications [ Time Frame: 30 days ]
    Infection, bleeding, stroke, pseudoaneurysm formation, etc.

  2. All cause mortality [ Time Frame: 30 days ]
    Post procedural death.


Secondary Outcome Measures :
  1. Stroke [ Time Frame: 7 days ]
    Physical examination and magnetic resonance imaging (MRI) brain.

  2. Cognitive Decline [ Time Frame: 7 days ]
    Montreal cognitive assessment testing.

  3. Silent Infarction [ Time Frame: 7 days ]
    MRI brain.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03998631


Contacts
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Contact: Kong Teng Tan, MD, FRCPC 416-340-4800 ext x6166 kongteng.tan@uhn.ca

Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Kong Teng Tan, MD, FRCPC University Health Network, Toronto

Publications of Results:
Other Publications:

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Responsible Party: Kongteng Tan, Principal Investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03998631     History of Changes
Other Study ID Numbers: 19-5219
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data with other researchers.

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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.: Yes
Additional relevant MeSH terms:
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Brain Ischemia
Cerebral Infarction
Aneurysm
Aortic Aneurysm
Aortic Valve Stenosis
Aortic Aneurysm, Thoracic
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Stroke