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

NCT06337890 | Recruiting

• 1 other identifier: FEZECO
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Aortic Aneurysm

Keywords

FEVAR; CO2; Complex aortic aneurysm

Outcome Measures

Primary Outcomes (7)

• 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

  24-hour

• Reintervention and mortality

  In-hospital/30-day

  30-day

• Number of participants with perioperative renal function worsening

  according to RIFLE classification

  30-day

• Rate of TVVs instability

  Freedom from TVVs instability

  through study completion, an average of 1 year

• Rate of survival

  Survival

  through study completion, an average of 1 year

• Rate of reintervention

  Freedom from reintervention

  through study completion, an average of 1 year

• Number of participants with renal function worsening

  Freedom from renal function worsening

  through study completion, an average of 1 year

Study Arms (1)

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

Interventions

Zero contrast FEVAR PROCEDURE

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

CO2 FEVAR

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Age \<18 years at the time of diagnosis

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

University of Bologna

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Enrico Gallitto

  University of Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Gallitto

CONTACT

0512143288; enrico.gallitto@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 29, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

IT (1)