Comparison of Carbon Dioxide Flush and Saline Flush to Saline Flush Alone in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia
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|ClinicalTrials.gov Identifier: NCT03998631|
Recruitment Status : Not yet recruiting
First Posted : June 26, 2019
Last Update Posted : June 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Aortic Aneurysm Aortic Stenosis Symptomatic Stroke, Complication||Procedure: Carbon Dioxide and Saline Flush Procedure: Standard Saline Flush||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Carbon Dioxide Flush and Saline Flush to Saline Flush Alone in TEVAR and TAVI Procedures to Reduce Cerebral Ischemia|
|Estimated Study Start Date :||June 15, 2019|
|Estimated Primary Completion Date :||October 15, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Placebo Comparator: 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.
Procedure: Standard Saline Flush
Standard of care flushing of the TEVAR or TAVI device with normal saline.
Experimental: Carbon Dioxide and Saline Flush
Carbon dioxide flush of the TEVAR or TAVI device followed by saline flush.
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.
- Complications [ Time Frame: 30 days ]Infection, bleeding, stroke, pseudoaneurysm formation, etc.
- All cause mortality [ Time Frame: 30 days ]Post procedural death.
- Stroke [ Time Frame: 7 days ]Physical examination and magnetic resonance imaging (MRI) brain.
- Cognitive Decline [ Time Frame: 7 days ]Montreal cognitive assessment testing.
- Silent Infarction [ Time Frame: 7 days ]MRI brain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998631
|Contact: Kong Teng Tan, MD, FRCPC||416-340-4800 ext email@example.com|
|Principal Investigator:||Kong Teng Tan, MD, FRCPC||University Health Network, Toronto|