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出境医 / 临床实验 / Comparison of Carbon Dioxide and Saline Flush to Saline Flush in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia

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

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
Thoracic Aortic Aneurysm Aortic Stenosis Symptomatic Stroke, Complication Procedure: Carbon Dioxide and Saline Flush Procedure: Standard Saline Flush Phase 1

Study Design
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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
Actual Study Start Date : July 20, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 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 [ 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. Silent Infarction [ Time Frame: 7 days ]
    MRI brain.


Eligibility Criteria
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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
Contacts and Locations

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

Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Kong Teng Tan, MD    416 340-3111      
Principal Investigator: Kong Teng Tan, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Kong Teng Tan, MD, FRCPC University Health Network, Toronto
Tracking Information
First Submitted Date  ICMJE June 24, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date September 23, 2020
Actual Study Start Date  ICMJE July 20, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Complications [ Time Frame: 30 days ]
    Infection, bleeding, stroke, pseudoaneurysm formation, etc.
  • All cause mortality [ Time Frame: 30 days ]
    Post procedural death.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2020)
  • Stroke [ Time Frame: 7 days ]
    Physical examination and magnetic resonance imaging (MRI) brain.
  • Silent Infarction [ Time Frame: 7 days ]
    MRI brain.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Stroke [ Time Frame: 7 days ]
    Physical examination and magnetic resonance imaging (MRI) brain.
  • Cognitive Decline [ Time Frame: 7 days ]
    Montreal cognitive assessment testing.
  • Silent Infarction [ Time Frame: 7 days ]
    MRI brain.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Carbon Dioxide and Saline Flush to Saline Flush in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia
Official Title  ICMJE Comparison of Carbon Dioxide Flush and Saline Flush to Saline Flush Alone in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Thoracic Aortic Aneurysm
  • Aortic Stenosis Symptomatic
  • Stroke, Complication
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Standard Saline Flush
  • Experimental: Carbon Dioxide and Saline Flush
    Carbon dioxide flush of the TEVAR or TAVI device followed by saline flush.
    Intervention: Procedure: Carbon Dioxide and Saline Flush
Publications *
  • Gutsche JT, Cheung AT, McGarvey ML, Moser WG, Szeto W, Carpenter JP, Fairman RM, Pochettino A, Bavaria JE. Risk factors for perioperative stroke after thoracic endovascular aortic repair. Ann Thorac Surg. 2007 Oct;84(4):1195-200; discussion 1200.
  • Bechara CF. Commentary: Eliminating Air From Stent-Grafts During Arch Endovascular Therapy: One Step Closer to Reducing Stroke. J Endovasc Ther. 2019 Feb;26(1):81-82. doi: 10.1177/1526602818819922. Epub 2018 Dec 21.
  • Lansky AJ, Brown D, Pena C, Pietras CG, Parise H, Ng VG, Meller S, Abrams KJ, Cleman M, Margolis P, Petrossian G, Brickman AM, Voros S, Moses J, Forrest JK. Neurologic Complications of Unprotected Transcatheter Aortic Valve Implantation (from the Neuro-TAVI Trial). Am J Cardiol. 2016 Nov 15;118(10):1519-1526. doi: 10.1016/j.amjcard.2016.08.013. Epub 2016 Aug 23.
  • Perera AH, Rudarakanchana N, Monzon L, Bicknell CD, Modarai B, Kirmi O, Athanasiou T, Hamady M, Gibbs RG. Cerebral embolization, silent cerebral infarction and neurocognitive decline after thoracic endovascular aortic repair. Br J Surg. 2018 Mar;105(4):366-378. doi: 10.1002/bjs.10718. Epub 2018 Feb 12.
  • Rohlffs F, Tsilimparis N, Saleptsis V, Diener H, Debus ES, Kölbel T. Air Embolism During TEVAR: Carbon Dioxide Flushing Decreases the Amount of Gas Released from Thoracic Stent-Grafts During Deployment. J Endovasc Ther. 2017 Feb;24(1):84-88. doi: 10.1177/1526602816675621. Epub 2016 Oct 26.
  • Kölbel T, Rohlffs F, Wipper S, Carpenter SW, Debus ES, Tsilimparis N. Carbon Dioxide Flushing Technique to Prevent Cerebral Arterial Air Embolism and Stroke During TEVAR. J Endovasc Ther. 2016 Apr;23(2):393-5. doi: 10.1177/1526602816633705. Epub 2016 Feb 19.
  • Cheng D, Martin J, Shennib H, Dunning J, Muneretto C, Schueler S, Von Segesser L, Sergeant P, Turina M. Endovascular aortic repair versus open surgical repair for descending thoracic aortic disease a systematic review and meta-analysis of comparative studies. J Am Coll Cardiol. 2010 Mar 9;55(10):986-1001. doi: 10.1016/j.jacc.2009.11.047. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kong Teng Tan, MD, FRCPC 416-340-4800 ext x6166 kongteng.tan@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03998631
Other Study ID Numbers  ICMJE 19-5219
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
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to share data with other researchers.
Responsible Party Kongteng Tan, University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kong Teng Tan, MD, FRCPC University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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