An Innovative Approach to Automated Carbon Dioxide Angiography During Endovascular Abdominal Aortic Aneurysm Repair

N/ACompletedNCT04721951

University of Bologna65 enrolled

Overview

The study aims to perform Endovascular Aortic Repair procedures with CO2-Angiography using a standardized an operative Protocol

Study Type

OBSERVATIONAL

Enrollment

Conditions

Abdominal Aortic Aneurysm

Interventions

Endovascular Aortic Repair using Carbon Dioxide AngiographyPROCEDURE

Endovascular Aortic Repair using Carbon Dioxide Angiography

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 18 years * Male, female * Patients with indication for AAA * Informed consent achievement Exclusion Criteria: * Severe COPD (Chronic Obstructive Pulmonary Disease) * Known atrium- or ventricular septal defect with right-left-shunt * Severe renal arteries atherosclerosis * Ruptured AAA * Current partecipation in other interventional studies

Locations (1)

Department of experimental diagnostic and specialty medicine - Vascular Surgery

Bologna, Italy

Outcomes

Primary Outcomes

Technical Success

Technical success to assess the renal ostia and the hypogastric arteries (defined as 100% accuracy correlated to the iodinated contrast agent angiography or IVUS/FUSION techniques)

Time frame: 30 Days

Secondary Outcomes

Image Quality

Image quality for guiding the procedure defined as good for stent-graft implantation or low not allowing stent-graft implantation

Time frame: 30 Days

Endoleak Detection

Type I-IV endoleak detection

Time frame: 30 Days

CO2 Quantity

Amount of CO2 at each deployment step (renal arteries, right/left hypogastric artery, final angiography)

Time frame: 30 Days

Aneurysm Exclusion

Aneurysm exclusion without type I or III endoleaks at the CT scan at discharge

Time frame: 30 Days

Adverse Events

Any adverse event within 24 hours

Time frame: 30 Days

Data from ClinicalTrials.gov

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