About this trial
The study aims to evaluate the clinical and economic efficacy of a "Fast-Track" protocol for the elective endovascular treatment (EVAR) of infrarenal abdominal aortic aneurysms (AAA). The protocol minimizes invasiveness through the use of local/locoregional anesthesia, a total percutaneous approach, and the avoidance of routine Intensive Care Unit (ICU) admission. The primary goal is to reduce hospital Length of Stay (LOS) to \<48 hours and decrease procedural costs, while maintaining safety and increasing patient turnover compared to the standard of care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient diagnosed with infrarenal Abdominal Aortic Aneurysm (AAA) indicated for elective endovascular repair.
Patient diagnosed with Penetrating Aortic Ulcer (PAU) indicated for elective endovascular repair.
Patient resident in the Bologna metropolitan area OR able to remain within the area for at least 7 days post-procedure.
Patient with a cohabitant or caregiver available (cannot live alone) to ensure safety during the early post-discharge phase.
Disqualifiers
Patient resident outside the Bologna metropolitan area or unable to remain within the area for at least 7 days post-procedure.
Patient without a cohabitant or caregiver available
Common femoral arteries diameter <7 mm
Common femoral arteries with severe calcification (> 50% of vessel circumference), unsuitable for percutaneous closure device
Trial population
The study population consists of adult patients diagnosed with infrarenal Abdominal Aortic Aneurysm (AAA) or Penetrating Aortic Ulcer (PAU) referred to the Vascular Surgery Unit of Policlinico Sant'Orsola (a tertiary academic medical center). Participants are selected from the standard waiting list for elective repair based on anatomical suitability for a percutaneous approach (Green/Yellow patterns) and social eligibility for the fast-track early discharge protocol.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Technical Success
Technical success is defined as a single composite endpoint. A participant is considered to have achieved technical success only if all of the following criteria are met: successful deployment of the endograft with exclusion of the aneurysm, absence of type I/III endoleaks, patent access vessels, and no conversion to open surgery.. Unit of Measure: Percentage of participants
30-Day Aorta-Related Mortality
This outcome is reported as a single overall percentage. Aorta-related mortality is defined as death resulting from any of the following causes: directly attributable to the aortic pathology (e.g., rupture, progression of disease) OR complications related to the procedure/device. A participant experiencing death from any of these specific causes is counted only once towards this single aggregate percentage. Unit of Measure: Percentage of participants
Secondary outcomes
Mean Length of Stay (LOS)
The duration of the hospital stay, calculated from the date of admission for the procedure to the date of hospital discharge.
ICU Admission Rate
The overall rate of admission to the Intensive Care Unit (ICU). This includes both planned and unplanned admissions. It will be reported as a single overall percentage of participants who required an ICU stay. Unit of Measure: Percentage of participants
30-Day Mortality and Morbidity
This is defined as a single composite endpoint. It will be reported as the overall percentage of participants who experience at least one of the following events: all-cause mortality OR major adverse events (specifically: re-intervention, conversion to open surgery, or access site complications). A participant experiencing more than one of these events is counted only once towards this single aggregate percentage. Unit of Measure: Percentage of participants
Patient Turnover Rate
Description: The percentage increase in the total annual volume of Endovascular Aneurysm Repair (EVAR) cases treated at the study site(s) during the 1-year study period, calculated relative to the baseline year of 2025. This outcome is evaluated at the institutional level and will be reported as a single overall percentage. Unit of Measure: Percentage
Locations
Sponsors and contacts
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