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

NCT07431047 | Not Yet Recruiting

• 1 other identifier: EVAR-FT-BO2026
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Abdominal Aortic Aneurysm; Infrarenal Abdominal Aortic Aneurysm; Penetrating Aortic Ulcers (PAUs); Iliac Aneurysm

Keywords

EVAR; Fast-track Surgery; Local Anesthesia; Percutaneous Access; Cost-Benefit Analysis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Mean Length of Stay (LOS)

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

• ICU Admission Rate

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

• 30-Day Mortality and Morbidity

  30 days

• Patient Turnover Rate

  1 year

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead

Related Publications (6)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Penetrating Atherosclerotic Ulcer; Iliac Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Acute Aortic Syndrome; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 24, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share