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

March 22, 2024 updated by: Enrico Gallitto, University of Bologna

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).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Emilia Romagna
      • Bologna, Emilia Romagna, Italy, 40138
        • Recruiting
        • University of Bologna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age <18 years at the time of diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CO2 FEVAR
Use of automated CO2 angiographies combined with Fusion Imaging in patients with complex aortic aneurysms to obtain zero- or near zero- contrast FEVAR
Procedure: Zero contrast FEVAR
Use of automated CO2 angiographies with Fusion Imaging for zero contrast FEVAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of technical success
Time Frame: 24-hour
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
24-hour
Reintervention and mortality
Time Frame: 30-day
In-hospital/30-day
30-day
Number of participants with perioperative renal function worsening
Time Frame: 30-day
according to RIFLE classification
30-day
Rate of TVVs instability
Time Frame: through study completion, an average of 1 year
Freedom from TVVs instability
through study completion, an average of 1 year
Rate of survival
Time Frame: through study completion, an average of 1 year
Survival
through study completion, an average of 1 year
Rate of reintervention
Time Frame: through study completion, an average of 1 year
Freedom from reintervention
through study completion, an average of 1 year
Number of participants with renal function worsening
Time Frame: through study completion, an average of 1 year
Freedom from renal function worsening
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Investigators

  • Principal Investigator: Enrico Gallitto, University of Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEZECO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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