UnknownPhase 1

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

Canada20 participantsStarted 2019-07-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Complications

Timeframe: 30 days

All cause mortality

Timeframe: 30 days

Trial details

NCT IDNCT03998631

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

Contact for this trial

Kong Teng Tan, MD, FRCPC

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