NCT03998631

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

July 20, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

June 24, 2019

Last Update Submit

September 21, 2020

Conditions

Thoracic Aortic AneurysmAortic Stenosis SymptomaticStroke, Complication

Outcome Measures

Primary Outcomes (2)

  • Complications

    Infection, bleeding, stroke, pseudoaneurysm formation, etc.

    30 days

  • All cause mortality

    Post procedural death.

    30 days

Secondary Outcomes (2)

  • Stroke

    7 days

  • Silent Infarction

    7 days

Study Arms (2)

Saline Flush

PLACEBO COMPARATOR

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

Carbon Dioxide and Saline Flush

EXPERIMENTAL

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

Procedure: Carbon Dioxide and Saline Flush

Interventions

Carbon Dioxide and Saline FlushPROCEDURE

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.

Also known as: Cook Zenith alpha thoracic endovascular graft, Sapien Transcatheter Heart Valve, CoreValve Trascatheter Aortic Valve
Carbon Dioxide and Saline Flush
Standard Saline FlushPROCEDURE

Standard of care flushing of the TEVAR or TAVI device with normal saline.

Also known as: Cook Zenith alpha thoracic endovascular graft, Sapien Transcatheter heart valve, Core Valve Transcatheter Aortic Valve
Saline Flush

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective TEVAR or TAVI
  • Over 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Related Publications (7)

  • 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.

    PMID: 17888969BACKGROUND

  • 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.

    PMID: 30572774BACKGROUND

  • 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.

    PMID: 27645761BACKGROUND

  • 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.

    PMID: 29431856BACKGROUND

  • 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.

    PMID: 27798380BACKGROUND

  • 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.

    PMID: 26896417BACKGROUND

  • 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.

    PMID: 20137879RESULT

MeSH Terms

Conditions

Aortic Aneurysm, ThoracicStroke

Interventions

Carbon Dioxide

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Carbon Compounds, InorganicInorganic ChemicalsGasesOxidesOxygen Compounds

Study Officials

  • Kong Teng Tan, MD, FRCPC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kong Teng Tan, MD, FRCPC

CONTACT

416-340-4800kongteng.tan@uhn.ca

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 26, 2019

Study Start

July 20, 2019

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

September 23, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

No plan to share data with other researchers.

Locations

CA(1)