Condition: Type B Acute Aortic Syndrome · Thoracic and Thoracoabdominal Aneurysms With Crawford Extent I, II, III, or IV · Sponsor: University of Bologna
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 and reaching up to 16% in more complex endovascular interventions. Cerebral embolization caused by solid and gaseous particles is considered the main cause of perioperative stroke and silent brain infarction (SBI), the latter being defined as ischemic brain injury detected by neuroradiological imaging in the absence of immediate clinical symptoms. During TEVAR, approximately 90% of microembolic signals detected in the middle cerebral artery are caused by gaseous emboli, with the highest number occurring during endograft deployment. This phenomenon is associated with the manufacturing and ster…
This description comes directly from the study's public registry record.
Mauro Gargiulo, MD · 0512144252 · mauro.gargiulo2@unibo.it
Chiara Mascoli, MD · 0512144278 · chiara.mascoli@aosp.bo.it
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| 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 |
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Source record: clinicaltrials.gov/study/NCT07734584