Optimizing CO2 Injection Technique for EVAR

NCT05304026 | Unknown

• 1 other identifier: CO2 IT
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Automated carbon dioxide (CO2) angiography is considered a safe diagnostic alternative to standard iodinated contrast medium (ICM) for endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA), especially in patients with preoperative renal function impairment. Recent literature experiences describe the use of automated CO2 angiography in EVAR. One of the main issues of CO2 angiography is the inability to detect the origin of the lowest renal artery (proximal neck visualization) that was estimated up to 38%. In these experiences, the CO2 automated angiography is usually performed by a 5F pigtail catheter placed at renal arteries level. The aim of the study is to evaluate the efficacy of a new automated CO2 injection technique by a 5F introducer (single hole catheter) positioned at the distal level of the proximal neck in detecting both renal arteries in the first diagnostic and completion angiographies.

Conditions

Abdominal Aortic Aneurysm; Endovascular Aortic Repair

Keywords

CO2; contrast medium; angiography

Outcome Measures

Primary Outcomes (2)

• Aortic neck detection

  Define the efficacy of the alternative CO2 injection technique in the detection of renal arteries in those cases when the usual technique doesn't succeed.

  At the moment of CO2 injection during the procedure

• Procedure success

  Define the efficacy of the alternative CO2 injection technique in the detection of renal arteries, hypogastric arteries and endoleaks at the final angiography in those cases when the usual technique doesn't succeed.

  At the moment of CO2 injection during the procedure

Secondary Outcomes (4)

• CO2 complications

  within 30 days from the procedure

• Mortality

  within 30 days from the procedure

• Adverse events

  within 30 days from the procedure

• Rate of early reintervention

  within 30 days from the procedure

Study Arms (1)

Population

The group includes all patients undergoing EVAR, each patient is considered as both case and control of himself as the two CO2 injection techniques, through the 5F pigtail and through the 5F introducer, are both used during the procedure.

Device: Technique 1; Device: Technique 2; Device: Technique 3; Device: Technique 4

Interventions

Technique 1 DEVICE

It refers to CO2 digital subtraction angiographies performed at the beginning of the procedure through a 5F pigtail catheter placed at the level of renal arteries to identify the lowest renal artery.

Population

Technique 2 DEVICE

It refers to CO2 digital subtraction angiographies performed at the beginning of the procedure through a 5F introducer placed at the end of the proximal sealing zone to identify the lowest renal artery.

Population

Technique 3 DEVICE

It refers to CO2 digital subtraction angiographies performed at the end of the procedure through a 5F pigtail catheter through the pigtail catheter placed at the level of renal arteries.

Population

Technique 4 DEVICE

It refers to CO2 digital subtraction angiographies performed at the end of the procedure through a 5F introducer placed at the level of the contralateral iliac limb.

Population

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All elective patients with asymptomatic infrarenal abdominal aortic aneurysm (according to the ESVS guidelines) undergoing EVAR with automated CO2 digital subtraction angiography (DSA) from January 2021.

You may qualify if:

• Patients with asymptomatic infrarenal abdominal aortic aneurysm admitted to the S. Orsola - Malpighi Hospital for a planned EVAR procedure. All patients underwent a preoperative computed tomography angiography (CTA) with a \<2mm slices.

You may not qualify if:

• Patients with contraindication for CO2 (cardiac septal defects, pulmonary arteriovenous malformations, pulmonary hypertension, severe emphysema)
• Patients requiring advanced aortic repair (FEVAR, BEVAR)
• Urgent cases

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

University of Bologna

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Related Publications (4)

• Mascoli C, Faggioli G, Gallitto E, Vento V, Pini R, Vacirca A, Indelicato G, Gargiulo M, Stella A. Standardization of a Carbon Dioxide Automated System for Endovascular Aortic Aneurysm Repair. Ann Vasc Surg. 2018 Aug;51:160-169. doi: 10.1016/j.avsg.2018.01.099. Epub 2018 Mar 6.

  PMID: 29522871 BACKGROUND

• Gallitto E, Faggioli G, Vacirca A, Pini R, Mascoli C, Fenelli C, Logiacco A, Abualhin M, Gargiulo M. The benefit of combined carbon dioxide automated angiography and fusion imaging in preserving perioperative renal function in fenestrated endografting. J Vasc Surg. 2020 Dec;72(6):1906-1916. doi: 10.1016/j.jvs.2020.02.051. Epub 2020 Apr 8.

  PMID: 32276017 BACKGROUND

• Mascoli C, Faggioli G, Gallitto E, Vento V, Indelicato G, Pini R, Vacirca A, Stella A, Gargiulo M. The Assessment of Carbon Dioxide Automated Angiography in Type II Endoleaks Detection: Comparison with Contrast-Enhanced Ultrasound. Contrast Media Mol Imaging. 2018 Mar 26;2018:7647165. doi: 10.1155/2018/7647165. eCollection 2018.

  PMID: 29780288 BACKGROUND

• Vacirca A, Faggioli G, Mascoli C, Gallitto E, Pini R, Spath P, Logiacco A, Palermo S, Gargiulo M. CO2 Automated Angiography in Endovascular Aortic Repair Preserves Renal Function to a Greater Extent Compared with Iodinated Contrast Medium. Analysis of Technical and Anatomical Details. Ann Vasc Surg. 2022 Apr;81:79-88. doi: 10.1016/j.avsg.2021.10.039. Epub 2021 Nov 14.

  PMID: 34785338 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Enrico Gallitto, MD, PhD

  University of Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Gallitto, MD, PhD

CONTACT

+390512143288; 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 3, 2022
• First Posted: March 31, 2022
• Study Start: January 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: September 15, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

IT (1)