AzTrials
AzTrials

Aortic AneurysmNCT06337890

CO2 Automated Angiographies With Fusion Imaging for Zero- or Near Zero- Contrast FEVAR.

An observational study of Aortic Aneurysm, run by University of Bologna at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Fenestrated endovascular aneurysm repair (FEVAR) is an established technique used to treat complex aortic aneurysms (TAAAs), with satisfactory early and midterm results. Postoperative renal function worsening is a common adverse event after FEVAR of complex aneurysms and is associated with prolonged hospital stay… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Aortic Aneurysm
What is being tested?
Zero contrast FEVAR
Type of treatment
Surgery or procedure
How many people
40 participants
Where
1 siteItaly
Study dates
1 Jan 2024to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All the patients with complex aortic aneurysms (according to SVS guidelines) that undergo FEVAR with automated CO2 angiographies combined with Fusion Imaging to reduce the amount of iodinated contrast medium

Who may be able to join

  • Patients with complex aortic aneurysms eligible for FEVAR.
  • Obtaining informed consent.
  • Age >18 years at the time of diagnosis

Who cannot join

  • Age <18 years at the time of diagnosis

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting
  • University of Bologna

    Bologna, Emilia-Romagna, 40138

    Enrico Gallitto, MD, PhD, +390512143288, enrico.gallitto@gmail.com

    Recruiting

Other trials in Italy

About this study

Official title: The Use of CO2 Automated Angiographies Combined With Fusion Imaging to Obtain Zero- or Near Zero- Contrast FEVAR for Complex Aortic Aneurysms.

Fenestrated endovascular aneurysm repair (FEVAR) is an established technique used to treat complex aortic aneurysms (TAAAs), with satisfactory early and midterm results.

Postoperative renal function worsening is a common adverse event after FEVAR of complex aneurysms and is associated with prolonged hospital stay, higher morbidity, and long-term mortality in the peri-operative period and during follow-up. One of the more common causes of renal function worsening is contrast-induced nephropathy resulting from the use of iodinated contrast medium (ICM).

Read more

Automated carbon dioxide (CO2) angiography has been proposed as an alternative to ICM for standard endovascular aneurysm repair (EVAR) in consideration of its absence of nephrotoxicity that can be of further help in preserving renal function.

In adjunct, hybrid room and fusion imaging (FI) technologies are useful tools to reduce intraoperative contrast medium and fluoroscopy time.

In literature there are few reports regarding the use of CO2 for fenestrated endografting repair of complex aortic aneurysms.

The aim of the present study is to report the possibility to combine the use of automated CO2 angiographies and Fusion Imaging to obtain zero- or near zero- contrast FEVAR for complex aortic aneurysms.

Read the detailed description

Fenestrated endovascular aneurysm repair (FEVAR) is an established technique used to treat juxtarenal and pararenal abdominal aortic aneurysms (AAAs) and type IV thoracoabdominal aortic aneurysms (TAAAs), as demonstrated by early and midterm literature results.

Postoperative renal function worsening is a common adverse event after FEVAR of complex aneurysms and is associated with prolonged hospital stay, higher morbidity, and long-term mortality in the peri-operative period and during follow-up.

Renal function may worsen after FEVAR because of a variety of factors, but one of the more common causes of renal function worsening is contrast-induced nephropathy resulting from the use of iodinated contrast medium (ICM).

Automated CO2 angiography has been proposed as an alternative to ICM for standard endovascular aneurysm repair (EVAR) in consideration of its absence of nephrotoxicity that can be of further help in preserving renal function.

In adjunct, hybrid room and fusion imaging (FI) technologies, based on a three-dimensional preoperative computed tomography angiography (CTA) image over-laid on a two-dimensional live fluoroscopy image, are useful tools to reduce intraoperative contrast medium and fluoroscopy time.

The aim of the present study is to report the possibility to combine the use of automated CO2 angiographies and Fusion Imaging to obtain zero- or near zero- contrast FEVAR for complex aortic aneurysms.

ENDPOINTS

Early: - Technical success (defined as correct endograft deployment with stenting and patency of all planned target visceral vessels (TVVs) and absence of type I and type III endoleaks, iliac leg stenosis or kinking and mortality at 24 hours)

  • in-hospital/30-day reintervention and mortality
  • perioperative renal function worsening (according to the RIFLE, Risk, Injury, Failure, Loss of kidney function, End-stage renal disease, criteria)

Follow-up: - Freedom from TVVs instability

  • Survival
  • Freedom from reintervention
  • Freedom from renal function worsening

CO2 Injection protocol

Diagnostic CO2 angiographies are performed in the anteroposterior and 90-degree lateral projections from a 6F sheet, positioned in the pararenal aorta, by an automated CO2 injector (Angiodroid; San Lazzaro, Bologna, Italy).

The FI/VesselNavigator is optimized with these two CO2 angiography images and the TVV origins. The injection pressure and volume are usually set at 650 mmHg and 100 ml, respectively. Carbon dioxide angiographies are repeated step by step after endograft introduction and during endograft deployment to adjust the endograft's position according to fusion images.

To evaluate cannulation and bridging stentgraft deployment in each TVVs CO2 angiographies are performed with the 6F sheet for superior mesenteric artery and, for the other TVVs, with selective angiographies through the TVVs sheet.

In this case, the injection pressure is set at 300 mmHg while the injection volume is set at 40 mL.

The angiographic shots required to deploy the bifurcated graft and the contralateral iliac leg are usually performed through an automated CO2 injection from the femoral sheaths.

Completion angiography is performed through 6F sheet positioned in the proximal portion of the endograft, in both anteroposterior and lateral views.

FOLLOW-UP

30-day: CTA scan + blood tests 3 months: duplex ultrasound (DUS) or CTA scan (in case of any doubt) + blood tests 6 months: DUS + blood tests 12 months: CTA scan + blood tests

During the follow-up, clinical evaluations will be performed as per standard clinical practice for patients with this condition.

Conditions
Aortic Aneurysm
Being tested
Zero contrast FEVAR
Keywords
FEVAR, CO2, Complex aortic aneurysm
Medical subject headings
Aortic Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zero contrast FEVARProcedure or surgery

    Use of automated CO2 angiographies with Fusion Imaging for zero contrast FEVAR

Study groups in NCT06337890
Study groupRoleWhat they receive
CO2 FEVARUse of automated CO2 angiographies combined with Fusion Imaging in patients with complex aortic aneurysms to obtain zero- or near zero- contrast FEVAR
Receives: Procedure: Zero contrast FEVAR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of technical success

    correct endograft deployment with stenting and patency of all planned TVVs and absence of type I and type III endoleaks, iliac leg stenosis or kinking and mortality at 24 hours

    Measured: 24-hour

  2. Reintervention and mortality

    In-hospital/30-day

    Measured: 30-day

  3. Number of participants with perioperative renal function worsening

    according to RIFLE classification

    Measured: 30-day

  4. Rate of TVVs instability

    Freedom from TVVs instability

    Measured: through study completion, an average of 1 year

  5. Rate of survival

    Survival

    Measured: through study completion, an average of 1 year

  6. Rate of reintervention

    Freedom from reintervention

    Measured: through study completion, an average of 1 year

  7. Number of participants with renal function worsening

    Freedom from renal function worsening

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2024
  2. Study start1 Jan 2024
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06337890
Sponsor's protocol ID
FEZECO
Status last verified
Mar 2024
First submitted
18 Mar 2024
Last updated
29 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Aneurysm, run by University of Bologna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Enrico Gallitto (0512143288, enrico.gallitto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of technical success (time frame: 24-hour). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in