search
Back to results

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

Primary Purpose

Thoracic Aortic Aneurysm, Aortic Stenosis Symptomatic, Stroke, Complication

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Carbon Dioxide and Saline Flush
Standard Saline Flush
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Aortic Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Saline Flush

Carbon Dioxide and Saline Flush

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Complications
Infection, bleeding, stroke, pseudoaneurysm formation, etc.
All cause mortality
Post procedural death.

Secondary Outcome Measures

Stroke
Physical examination and magnetic resonance imaging (MRI) brain.
Silent Infarction
MRI brain.

Full Information

First Posted
June 24, 2019
Last Updated
September 21, 2020
Sponsor
University Health Network, Toronto
search

1. Study Identification

Unique Protocol Identification Number
NCT03998631
Brief Title
Comparison of Carbon Dioxide and Saline Flush to Saline Flush in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia
Official Title
Comparison of Carbon Dioxide Flush and Saline Flush to Saline Flush Alone in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Aortic Aneurysm, Aortic Stenosis Symptomatic, Stroke, Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline Flush
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Carbon Dioxide and Saline Flush
Arm Type
Experimental
Arm Description
Carbon dioxide flush of the TEVAR or TAVI device followed by saline flush.
Intervention Type
Procedure
Intervention Name(s)
Carbon Dioxide and Saline Flush
Other Intervention Name(s)
Cook Zenith alpha thoracic endovascular graft, Sapien Transcatheter Heart Valve, CoreValve Trascatheter Aortic Valve
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard Saline Flush
Other Intervention Name(s)
Cook Zenith alpha thoracic endovascular graft, Sapien Transcatheter heart valve, Core Valve Transcatheter Aortic Valve
Intervention Description
Standard of care flushing of the TEVAR or TAVI device with normal saline.
Primary Outcome Measure Information:
Title
Complications
Description
Infection, bleeding, stroke, pseudoaneurysm formation, etc.
Time Frame
30 days
Title
All cause mortality
Description
Post procedural death.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Stroke
Description
Physical examination and magnetic resonance imaging (MRI) brain.
Time Frame
7 days
Title
Silent Infarction
Description
MRI brain.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kong Teng Tan, MD, FRCPC
Phone
416-340-4800
Ext
x6166
Email
kongteng.tan@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kong Teng Tan, MD, FRCPC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kong Teng Tan, MD
Phone
416 340-3111
First Name & Middle Initial & Last Name & Degree
Kong Teng Tan, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data with other researchers.
Citations:
PubMed Identifier
17888969
Citation
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. doi: 10.1016/j.athoracsur.2007.04.128.
Results Reference
background
PubMed Identifier
30572774
Citation
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. No abstract available.
Results Reference
background
PubMed Identifier
27645761
Citation
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.
Results Reference
background
PubMed Identifier
29431856
Citation
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.
Results Reference
background
PubMed Identifier
27798380
Citation
Rohlffs F, Tsilimparis N, Saleptsis V, Diener H, Debus ES, Kolbel 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.
Results Reference
background
PubMed Identifier
26896417
Citation
Kolbel 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.
Results Reference
background
PubMed Identifier
20137879
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs