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A Standard Carbon Dioxide Flushing Protocol to Reduce Air Embolization During Thoracic Endovascular Aortic Repair

RecruitingNAAges 18 Years - anyAllUniversity of Bologna
NCT07734584 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

FlushTEVAR is a non-profit, interventional, randomized, controlled, single-blind, national multicenter study promoted by the University of Bologna and coordinated by the Vascular Surgery Unit of IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola, under the direction of Prof. Mauro Gargiulo, who also serves as Principal Investigator. The study aims to develop and evaluate a pre-implant thoracic endograft flushing technique using carbon dioxide (CO₂) to reduce periprocedural embolic events and cerebral infarctions in patients undergoing Thoracic Endovascular Aortic Repair (TEVAR). TEVAR is currently the treatment of choice for acute aortic syndromes and aneurysms involving the descending thoracic aorta. Despite its widespread use, TEVAR remains associated with significant neurological complications, with an incidence ranging from 3% to 8% in standard procedures

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • Carbon dioxide pre-implant endograft flushing followed by saline flushing
  • Saline endograft flushing
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Where

4 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
A.S.S.T. Spedali Civili di Brescia
Brescia, Italy
IRCCS Policlinico San Martino di Genova
Genova, Italy
Azienda Ospedaliero-Universitaria di Padova
Padova, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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