Comparison of Outcomes of Complex Abdominal Aortic Aneurysm Treatment

NCT04773223 | Completed Results

• 1 other identifier: Complex AAA surgery
• Study Type: observational
• Target: 925
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Open repair remains the gold standard for fit patients with complex AAA. In the past decade, an evolution of devices, design, components, and delivery systems expanded the application of EVAR in these challenging anatomies. Fenestrated stent-grafts are now commercially available for the repair of complex AAA in the United States and Europe. Initial reports have demonstrated a high technical success rate, low renal dysfunction rate, and low morbidity and mortality, with promising short- and long-term results. Other reports have shown excessive morbidity and mortality with fenestrated EVAR (FEVAR). Studies comparing endovascular and open repair are sparse, especially when it concerns long-term outcomes. There are till nowadays only two propensity score-matched studies, one showing worse short-term and another long-term clinical outcome for fenestrated-branched EVAR (F/BEVAR) over open surgical repair (OSR). Aim: The aim of this study will be to compare F/BEVAR versus open AAA repair on short- and long-term clinical outcomes for the treatment of juxta- and pararenal AAA. Methodology: This is a prospective cohort study from the four high-volume AAA repair centers: Belgrade/Serbia, Bologna/Italy, Milan/Italy, Dijklander/Netherland, Amsterdam/Netherland, and Helsinki/Finland. Data will be collected on demographics, baseline comorbidities, AAA parameters (diameter and localization), laboratory values, intra-, and postoperative data. Follow-up examinations (clinical visits and color duplex ultrasonography, CT scans) will be performed 1, 6, and 12 months after the intervention, and annually thereafter. Propensity score analysis will be performed by matching open repair patients to endovascularly treated controlling for demographics and baseline comorbidities. Endpoints: Primary endpoints are all-cause mortality and the freedom from aortic-related reintervention. The secondary endpoint is the 30-day complication rate, especially acute kidney injury according to the RIFLE criteria.

Conditions

Juxtarenal Aortic Aneurysm; Pararenal Aneurysm

Outcome Measures

Primary Outcomes (2)

• Aortic Related Reintervention.

  In open surgery this will include patients who were reoperated due to: graft infection, graft thrombosis, pseudoaneurysm formation, secondary AAA rupture. In endovascular group reintervention will include different reasons: endoleak, migration, thrombosis, infection, fracture, secondary AAA rupture.

  through study completion, an average of 7 year

• All-cause Mortality

  Any cause of mortality duing follow-up period

  through study completion, an average of 7 year

Secondary Outcomes (1)

• 30-day Acute Kidney Injury

  30-day acute kidney injury

Study Arms (2)

Open surgery group

Patients undergoing open surgery due to juxta/pararenal abdominal aortic aneurysm

Procedure: Open surgery and complex EVAR due to AAA

Endovascular group

Patients undergoing some form of endovascular abdominal aortic aneurysm repair: fenestrated, chimney, etc.

Procedure: Open surgery and complex EVAR due to AAA

Interventions

Open surgery and complex EVAR due to AAA PROCEDURE

There will be two cohorts: 1. Patient undergoing open surgery 2. Patients undergoing complex endovascular repair (fenestrated, chimney, etc.)

Endovascular group; Open surgery group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: more than 18 year old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with juxta/pararenal abdominal aortic aneurysm (AAA) undergoing either open surgery or complex endovascular repair. The definition of the juxtarenal AAA will include those with a short neck (less than 1cm). The definition of the pararenal AAA will include those where renal arteries originate from the aneurysm itself.

You may qualify if:

• All patients (over 18 years of age) with a history of juxta- and pararenal AAA repair from January 2011 to January 2022
• All management strategies will be included (endovascular and open)

You may not qualify if:

• Patients who are pregnant
• Patients who are under 18 years of age
• Patients who have ruptured AAA
• Patients with thoracoabdominal aortic aneurysm (ThAAA)
• Patients who have a mycotic AAA
• Patients with connective tissue disorder

Sponsors & Collaborators

• Clinical Centre of Serbia: lead
• Università Vita-Salute San Raffaele: collaborator
• Helsinki University Central Hospital: collaborator
• Dijklander Ziekenhuis: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator

Study Sites (1)

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Related Publications (4)

• Tinelli G, Crea MA, de Waure C, Di Tanna GL, Becquemin JP, Sobocinski J, Snider F, Haulon S. A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms. J Vasc Surg. 2018 Sep;68(3):659-668. doi: 10.1016/j.jvs.2017.12.060. Epub 2018 Mar 22.

  PMID: 29576405 BACKGROUND

• Raux M, Patel VI, Cochennec F, Mukhopadhyay S, Desgranges P, Cambria RP, Becquemin JP, LaMuraglia GM. A propensity-matched comparison of outcomes for fenestrated endovascular aneurysm repair and open surgical repair of complex abdominal aortic aneurysms. J Vasc Surg. 2014 Oct;60(4):858-63; discussion 863-4. doi: 10.1016/j.jvs.2014.04.011. Epub 2014 May 15.

  PMID: 24835042 BACKGROUND

• Roy IN, Millen AM, Jones SM, Vallabhaneni SR, Scurr JRH, McWilliams RG, Brennan JA, Fisher RK. Long-term follow-up of fenestrated endovascular repair for juxtarenal aortic aneurysm. Br J Surg. 2017 Jul;104(8):1020-1027. doi: 10.1002/bjs.10524. Epub 2017 Apr 12.

  PMID: 28401533 BACKGROUND

• Ferrante AM, Moscato U, Colacchio EC, Snider F. Results after elective open repair of pararenal abdominal aortic aneurysms. J Vasc Surg. 2016 Jun;63(6):1443-50. doi: 10.1016/j.jvs.2015.12.034. Epub 2016 Mar 16.

  PMID: 26994948 BACKGROUND

Results Point of Contact

• Title: Petar Zlatanovic
• Organization: University Clinical Centre of Serbia

petar91goldy@gmail.com

+381644961020

Study Officials

• Petar Zlatanovic, MD

  University Clinical Centre of Serbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: February 26, 2021
• Study Start: January 1, 2011
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: July 22, 2024
• Results First Posted: July 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)