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Optimizing CO2 Injection Technique for EVAR

NCT05304026 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-03-31

No results posted yet for this study

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

Interventions

DEVICE

Technique 1

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.

DEVICE

Technique 2

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.

DEVICE

Technique 3

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.

DEVICE

Technique 4

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.

Sponsors & Collaborators

  • University of Bologna

    lead OTHER

Principal Investigators

  • Enrico Gallitto, MD, PhD · University of Bologna

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-06-01
Completion
2022-09-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05304026 on ClinicalTrials.gov