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

Thoracic Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03998631
• Other study ID #: 19-5219
• Status: Recruiting
• Phase: Phase 1
• Start date: July 20, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: September 2020
• Source: University Health Network, Toronto
• Contact: Kong Teng Tan, MD, FRCPC
• Phone: 416-340-4800
• Email: kongteng.tan[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Stenosis Symptomatic
• Aortic Valve Stenosis
• Brain Ischemia
• Cerebral Infarction
• Ischemia
• Stroke, Complication
• Thoracic Aortic Aneurysm

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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. — View 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 stud — View 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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	Infection, bleeding, stroke, pseudoaneurysm formation, etc.	30 days
Primary	All cause mortality	Post procedural death.	30 days
Secondary	Stroke	Physical examination and magnetic resonance imaging (MRI) brain.	7 days
Secondary	Silent Infarction	MRI brain.	7 days