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

Fast-Track Protocol for Infrarenal EVAR

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Abdominal Aortic Aneurysm; Iliac Aneurysm; Penetrating Aortic Ulcers (PAUs); Infrarenal Abdominal Aortic Aneurysm

Detailed Description

Endovascular Aneurysm Repair (EVAR) is the guideline-recommended treatment for AAA. Despite its minimally invasive nature, standard pathways often involve general anesthesia (80% of historical cases at the institution) and ICU monitoring. The Vascular Surgery Unit at Policlinico Sant'Orsola proposes a structured Fast-Track protocol involving:

1. Strict Patient Selection: Based on anatomical suitability ("Green/Yellow" criteria) and social support availability.
2. Peri-operative Management: Same-day admission, procedure performed in a Hybrid Operating Room under local/locoregional anesthesia with percutaneous access. Minimization of invasive monitoring (no central venous catheter, no urinary catheter).
3. Post-operative Care: Early mobilization, oral intake on Day 0, and planned discharge on Post-Operative Day (POD) 1 or 2.
4. Follow-up: Telemedicine assessment on POD 3, outpatient visit on POD 6, and CT Angiography at 30 days. The study compares outcomes against historical data (Year 2025) to assess reductions in ICU usage, complications, and costs.

• Study Type: Observational
• Enrollment (Estimated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion criteria

• 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.
• Signed informed consent specifically for local/locoregional anesthesia, the procedure and the specific fast-track pathway.
• Common femoral arteries diameter > 7 mm
• Common femoral arteries free of severe calcification (< 50% of vessel circumference), suitable for percutaneous closure device
• Proximal aortic neck length > 15 mm
• Proximal aortic neck diameter < 30 mm
• Proximal aortic neck without severe angulation (<60°) or circumferential thrombus <50%

Exclusion Criteria:

• 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
• Proximal aortic neck length < 15 mm
• Proximal aortic neck diameter > 30 mm
• Proximal aortic neck with severe angulation (>60°) or circumferential thrombus >50%
• General anesthesia
• Open conversion
• Medical contraindication to local/locoregional anesthesia or patient refusal/inability to cooperate during the procedure.
• Severe Chronic Kidney Disease (glomerular filtration rate > 30 ml/min) requiring exclusively CO2 angiography
• Ruptured or symptomatic aneurysms requiring emergency repair.
• Clinical condition requiring intensive invasive monitoring (e.g., CVC, urinary catheter) prior to the procedure.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Fast-Track EVAR Cohort; Patients with infrarenal Abdominal Aortic Aneurysm (AAA) undergoing elective Endovascular Aneurysm Repair (EVAR) under local or locoregional anesthesia, managed with the multidisciplinary Fast-Track protocol (percutaneous access, early mobilization, and planned discharge within 24-48 hours).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Intra-operative
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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From hospital admission to discharge, assessed up to 30 days. Unit of Measure: Days
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: Intra-operative up to Post-Operative Day 1
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	30 days
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	1 year

Collaborators and Investigators

• Sponsor: University of Bologna

Publications and helpful links

General Publications

• Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2.
• Faggioli G, Scalone L, Mantovani LG, Borghetti F, Stella A; PREFER study group. Preferences of patients, their family caregivers and vascular surgeons in the choice of abdominal aortic aneurysms treatment options: the PREFER study. Eur J Vasc Endovasc Surg. 2011 Jul;42(1):26-34.
• Antoniou GA, Antoniou SA, Torella F. Editor's Choice - Endovascular vs. Open Repair for Abdominal Aortic Aneurysm: Systematic Review and Meta-analysis of Updated Peri-operative and Long Term Data of Randomised Controlled Trials. Eur J Vasc Endovasc Surg. 2020 Mar;59(3):385-397.
• Isselbacher EM, Preventza O, Hamilton Black J 3rd, Augoustides JG, Beck AW, Bolen MA, Braverman AC, Bray BE, Brown-Zimmerman MM, Chen EP, Collins TJ, DeAnda A Jr, Fanola CL, Girardi LN, Hicks CW, Hui DS, Schuyler Jones W, Kalahasti V, Kim KM, Milewicz DM, Oderich GS, Ogbechie L, Promes SB, Gyang Ross E, Schermerhorn ML, Singleton Times S, Tseng EE, Wang GJ, Woo YJ; Peer Review Committee Members. 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2022 Dec 13;146(24):e334-e482
• Wanhainen A, Van Herzeele I, Bastos Goncalves F, Bellmunt Montoya S, Berard X, Boyle JR, D'Oria M, Prendes CF, Karkos CD, Kazimierczak A, Koelemay MJW, Kölbel T, Mani K, Melissano G, Powell JT, Trimarchi S, Tsilimparis N; ESVS Guidelines Committee; Antoniou GA, Björck M, Coscas R, Dias NV, Kolh P, Lepidi S, Mees BME, Resch TA, Ricco JB, Tulamo R, Twine CP; Document Reviewers; Branzan D, Cheng SWK, Dalman RL, Dick F, Golledge J, Haulon S, van Herwaarden JA, Ilic NS, Jawien A, Mastracci TM, Oderich GS, Verzini F, Yeung KK. Editor's Choice - - European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2024 Feb;67(2):192-331.
• Pratesi C, Esposito D, Apostolou D, Attisani L, Bellosta R, Benedetto F, Blangetti I, Bonardelli S, Casini A, Fargion AT, Favaretto E, Freyrie A, Frola E, Miele V, Niola R, Novali C, Panzera C, Pegorer M, Perini P, Piffaretti G, Pini R, Robaldo A, Sartori M, Stigliano A, Taurino M, Veroux P, Verzini F, Zaninelli E, Orso M; Italian Guidelines for Vascular Surgery Collaborators - AAA Group. Guidelines on the management of abdominal aortic aneurysms: updates from the Italian Society of Vascular and Endovascular Surgery (SICVE). J Cardiovasc Surg (Torino). 2022 Jun;63(3):328-352.

Study record dates

Study Major Dates

• Study Start (Estimated): February 11, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cost-Benefit Analysis; EVAR; Local Anesthesia; Fast-track Surgery; Percutaneous Access
• Additional Relevant MeSH Terms: Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Penetrating Atherosclerotic Ulcer; Aortic Aneurysm, Abdominal; Iliac Aneurysm
• Other Study ID Numbers: EVAR-FT-BO2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No