Fast-Track Protocol for Endovascular Aneurysm Repair (EVAR) of Infrarenal Abdominal Aortic Aneurysms

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Bologna

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: Fast-Track EVAR Cohort

Trial outcomes

Primary outcomes

1

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

Time frame
Intra-operative
2

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

Time frame
30 days

Secondary outcomes

1

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.

Time frame
From hospital admission to discharge, assessed up to 30 days. Unit of Measure: Days
2

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

Time frame
Time Frame: Intra-operative up to Post-Operative Day 1
3

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

Time frame
30 days
4

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

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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