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

Phase 1

• Conditions: Stroke, Complication; Thoracic Aortic Aneurysm; Aortic Stenosis Symptomatic
• Interventions: Procedure: Carbon Dioxide and Saline Flush; Procedure: Standard Saline Flush

• Registration Number: NCT03998631
• Lead Sponsor: 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. 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 available

Study Timeline

• Study First Submitted: 2019-06-24
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-26
• Study Start: 2019-07-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-23
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Elective TEVAR or TAVI
• Over 18 years old

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbon Dioxide and Saline Flush	Carbon Dioxide and Saline Flush	Carbon dioxide flush of the TEVAR or TAVI device followed by saline flush.
Saline Flush	Standard 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.

Primary Outcome Measures

Name	Time	Method
All cause mortality	30 days	Post procedural death.
Complications	30 days	Infection, bleeding, stroke, pseudoaneurysm formation, etc.

Secondary Outcome Measures

Name	Time	Method
Silent Infarction	7 days	MRI brain.
Stroke	7 days	Physical examination and magnetic resonance imaging (MRI) brain.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada