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

NCT07431047 — Not yet recruiting, 50 participants, University of Bologna

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Fast-Track Protocol for Infrarenal EVAR

RegistryNCT07431047
StatusNot yet recruiting
Study typeObservational
Enrollment50 (Estimated)
SponsorUniversity of Bologna (Other)
ConditionsAbdominal Aortic Aneurysm, Infrarenal Abdominal Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs), Iliac Aneurysm
Datesstart 2026-02-11 (estimated), primary completion 2026-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-02-24, last updated 2026-02-24

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-Summary

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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Fast-Track EVAR CohortPatients 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).

+Outcome measures

Primary outcomes

  • Technical Success [Intra-operative]: 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 [30 days]: 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) [From hospital admission to discharge, assessed up to 30 days. Unit of Measure: Days]: The duration of the hospital stay, calculated from the date of admission for the procedure to the date of hospital discharge.
  • ICU Admission Rate [Time Frame: Intra-operative up to Post-Operative Day 1]: 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 [30 days]: 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 [1 year]: 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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+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. doi: 10.1016/j.jvs.2017.10.044. PMID 29268916
  • 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. doi: 10.1016/j.ejvs.2010.12.025. Epub 2011 Feb 19. PMID 21334928
  • 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. doi: 10.1016/j.ejvs.2019.11.030. Epub 2019 Dec 30. PMID 31899100
  • 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. doi: 10.1161/CIR.0000000000001106. Epub 2022 Nov 2. PMID 36322642
  • 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, Kolbel T, Mani K, Melissano G, Powell JT, Trimarchi S, Tsilimparis N; ESVS Guidelines Committee; Antoniou GA, Bjorck 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. doi: 10.1016/j.ejvs.2023.11.002. Epub 2024 Jan 23. PMID 38307694
  • 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. doi: 10.23736/S0021-9509.22.12330-X. PMID 35658387