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Optimizing CO2 Injection Technique for EVAR

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ClinicalTrials.gov Identifier: NCT05304026
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Enrico Gallitto, University of Bologna

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.


Condition or disease Intervention/treatment
Abdominal Aortic Aneurysm Endovascular Aortic Repair Device: Technique 1 Device: Technique 2 Device: Technique 3 Device: Technique 4

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Optimizing CO2 Injection Technique for Renal Artery Detection in Endovascular Abdominal Aortic Aneurysm Repair
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : September 15, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Aortic neck detection [ Time Frame: At the moment of CO2 injection during the procedure ]
    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.

  2. Procedure success [ Time Frame: At the moment of CO2 injection during the procedure ]
    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.


Secondary Outcome Measures :
  1. CO2 complications [ Time Frame: within 30 days from the procedure ]
    Evaluate CO2 induced complications rate

  2. Mortality [ Time Frame: within 30 days from the procedure ]
    Evaluate 30-day mortality related to procedure

  3. Adverse events [ Time Frame: within 30 days from the procedure ]
    Assessment of any cardiopulmonary and renal events related to the procedure

  4. Rate of early reintervention [ Time Frame: within 30 days from the procedure ]
    Any re-intervention needed after the procedure and the specific reason



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05304026


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

Locations
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Italy
University of Bologna Recruiting
Bologna, Emilia Romagna, Italy, 40138
Contact: Enrico Gallitto, MD, PhD    +390512143288    enrico.gallitto@gmail.com   
Sponsors and Collaborators
University of Bologna
Investigators
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Principal Investigator: Enrico Gallitto, MD, PhD University of Bologna
Publications:
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Responsible Party: Enrico Gallitto, Principal Investigator, University of Bologna
ClinicalTrials.gov Identifier: NCT05304026    
Other Study ID Numbers: CO2 IT
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enrico Gallitto, University of Bologna:
CO2
contrast medium
angiography
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases