Type B Acute Aortic SyndromeFlushTEVARNCT07734584
A Standard Carbon Dioxide Flushing Protocol to Reduce Air Embolization During Thoracic Endovascular Aortic Repair
A study testing Carbon dioxide pre-implant endograft flushing followed by saline flushing and Saline endograft flushing in people with Type B Acute Aortic Syndrome and Thoracic and Thoracoabdominal Aneurysms With Crawford Extent I, II, III, or IV, run by University of Bologna at 4 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type B Acute Aortic Syndrome, Thoracic and Thoracoabdominal Aneurysms With Crawford Extent I, II, III, or IV
- What is being tested?
- Carbon dioxide pre-implant endograft flushing followed by saline flushing and Saline endograft flushing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesItaly
- Study dates
- 15 Jul 2025to 15 Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Mauro Gargiulo, MD, 0512144252 ext. +39, mauro.gargiulo2@unibo.it
Mascoli Chiara, MD, 0512144278 ext. +39, chiara.mascoli@aosp.bo.it
- Not yet recruiting
A.S.S.T. Spedali Civili di Brescia
Brescia, Italy, 25123
Stefano Bonardelli, MD, 3332929425 ext. +39, stefano.bonardelli@unibs.it
Stefano Bonardelli, MD
- Not yet recruiting
IRCCS Policlinico San Martino di Genova
Genova, Italy, 16132
Giovanni Pratesi, MD, Giovanni.Pratesi@unige.it
Giovanni Pratesi, MD
- Not yet recruiting
Azienda Ospedaliero-Universitaria di Padova
Padova, Italy, 35128
Franco Grego, MD, 0498212638 ext. +39, franco.grego@unipd.it
Franco Grego, MD
About this study
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 sterilization processes of endografts, during which gas microparticles become trapped between the endograft and its delivery system and are subsequently released into the bloodstream when the device is deployed at the intended aortic site.
Read more
The primary objective of the study is to assess the difference in the incidence of major neurological events, including stroke and transient ischemic attack (TIA), as well as silent brain infarctions, between patients whose endografts undergo a standardized pre-implant flushing protocol with CO₂ followed by conventional saline flushing, and patients receiving standard saline flushing alone. Major neurological events will be assessed clinically, while silent brain infarctions will be evaluated using study-specific diffusion-weighted magnetic resonance imaging (DW-MRI) of the brain performed within 72 hours after the procedure.
A total of 90 patients will be enrolled across four participating centers and randomized in a 1:1 ratio after providing informed consent. Forty-five patients will be allocated to the experimental arm and treated with CO₂ flushing before the standard saline flushing procedure during TEVAR, while forty-five patients will be allocated to the control arm and will receive standard saline flushing only.
Eligible patients must be at least 18 years of age and present with type B acute aortic syndrome in the acute, subacute, or chronic phase, or thoracic and thoracoabdominal aneurysms with Crawford extent I, II, III, or IV. Written informed consent is required for participation. Patients will be excluded if the procedure is performed using CO₂ angiography, if endografts without a sheath are used, if emergency endovascular treatment is required, if they have experienced a stroke or TIA within the previous six months, if the proximal sealing zone is 0 or 1, if any contraindication to DW-MRI is present, or in cases of pregnancy or breastfeeding.
At study completion, the two treatment groups will be compared on the basis of diffusion-weighted brain MRI findings. The primary endpoint is the number of silent brain infarctions and the determination of whether a statistically significant difference exists between the CO₂ flushing group and the saline flushing group. The safety of the procedure will be evaluated through both technical and clinical success. The planned study duration is three years, and postoperative rates of SBI and TIA/stroke will be compared between groups using Fisher's and Pearson's chi-square tests.
- Conditions
- Type B Acute Aortic Syndrome, Thoracic and Thoracoabdominal Aneurysms With Crawford Extent I, II, III, or IV
- Being tested
- Carbon dioxide pre-implant endograft flushing followed by saline flushing, Saline endograft flushing
- Keywords
- TEVAR, CO2, aneurysm, flushing, silent brain infarctions, transient ischemic attack (TIA), stroke, endograft, aorta
- Medical subject headings
- Aneurysm, Flushing, Ischemic Attack, Transient, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon dioxide pre-implant endograft flushing followed by saline flushingProcedure or surgery
The CO2 flushing technique is conducted using an automated injector with the application of standard injection volume and pressure. Specifically, the endoprosthesis will be flushed from the side port of the delivery system with 3 CO2 injections at 750 mmHg of pressure and 100 cc of volume.
Saline endograft flushingProcedure or surgery
Following the IFU, the endograft delivery system will be flushed with 60 ml of saline solution at 0.9%.
| Study group | Role | What they receive |
|---|---|---|
| CO₂ flushing before the standard saline flushing procedure during TEVAR | Experimental | Not described Receives: Procedure: Carbon dioxide pre-implant endograft flushing followed by saline flushing; Procedure: Saline endograft flushing |
| only standard saline flushing procedure during TEVAR | Active comparator | Not described Receives: Procedure: Saline endograft flushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the number and location of SBI using study-specific diffusion-weighted magnetic resonance imaging (DW-MRI) and determine if there is a statistically significant difference of SBI number in the "CO2 arm", compared to the "saline solution arm".
The primary objective of the study is to assess the difference in terms of incidence (number) of ischaemic cerebral lesions, detected by DW-MRI after TEVAR, between patients whose endografts undergo a standardized pre-implant flushing protocol with CO₂ followed by conventional saline flushing, and patients receiving standard saline flushing alone,
Measured: Up to 72 hours after endovascular repair
Secondary outcomes (1)
Technical and clinical success
Technical success: successfull endograft deployment, patency, absence of type I-III endoleak, retrograde dissections.
Clinical success: absence of major stroke, death, paraplegia, major bleeding, acute kidney injury.
Measured: Peri-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start15 Jul 2025
- Primary completion15 Jul 2028 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type B Acute Aortic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- AngioDroid s.r.l., Bologna (Italy)
- Responsible party
- Principal investigator, Mauro Gargiulo, University of Bologna
- Investigators
- Mauro Gargiulo, MD, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734584
- Sponsor's protocol ID
- FlushTEVAR
- Other IDs
- Funding for a non-profit trial
- Acronym
- FlushTEVAR
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No