CO2 flushing before TEVAR to lower brain embolisms
Official title: A Standard Carbon Dioxide Flushing Protocol to Reduce Air Embolization During Thoracic Endovascular Aortic Repair
Run by University of Bologna · NCT07734584 · Data updated 2026-11-12
This study tests a carbon dioxide pre-flush protocol before placing thoracic endografts to see if it reduces brain embolisms in adults with type B acute aortic syndrome or certain thoracic aneurysms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | University of Bologna Academic / other |
| Locations | 4 sites (Bologna, Italy and 3 other locations) |
| Status | Recruiting |
| Started | July 15, 2025 |
| Main results expected | July 15, 2028 |
| Study ends | July 15, 2028 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT07734584 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older with type B acute aortic syndrome or thoracic/thoracoabdominal aneurysms (Crawford I–IV) undergoing TEVAR.
✕Probably not a fit
Patients who require emergency treatment, have recent stroke/TIA, or have contraindications to DW-MRI may not benefit or be excluded from benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
FlushTEVAR is a multicenter, randomized, single-blind interventional study led by the University of Bologna. It compares a pre-implant CO2 endograft flushing sequence followed by saline flushing against standard flushing during thoracic endovascular aortic repair. The goal is to see whether this CO2 technique lowers periprocedural embolic events and cerebral infarctions. Eligible patients include adults with type B acute aortic syndrome or specific Crawford-classified aneurysms. The trial is coordinated across several Italian centers and aligns with a non-profit research model.
Why it matters
Potential benefit: If successful, the protocol could reduce brain embolic events and improve outcomes after TEVAR.
How similar studies have gone: Prior TEVAR studies show neurological complications can be mitigated by technique refinements; this CO2 flushing approach is exploratory and novel in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age is at least 18 years * Present with type B acute aortic syndrome in the acute, subacute, or chronic phase * Thoracic and thoracoabdominal aneurysms with Crawford extent I, II, III, or IV * Written informed consent Exclusion Criteria: * Procedure performed using CO₂ angiography * Endografts without a sheath is used * Emergency endovascular treatment required * Patient has experienced a stroke or TIA within the previous six months * Proximal sealing zone is 0 or 1 * Any contraindication to DW-MRI * Pregnancy or breastfeeding
Where it's running
-
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, Italy Recruiting -
A.S.S.T. Spedali Civili di Brescia
Brescia, Italy, Italy Not yet recruiting -
IRCCS Policlinico San Martino di Genova
Genova, Italy, Italy Not yet recruiting -
Azienda Ospedaliero-Universitaria di Padova
Padova, Italy, Italy Not yet recruiting
Study contacts
- Principal investigator: Mauro Gargiulo, MD — University of Bologna
- Study coordinator: Mauro Gargiulo, MD
- Email: mauro.gargiulo2@unibo.it
- Phone: 0512144252
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.