Skip to main content
OpenTrials
Completed

NCT Number: NCT05247944

F-BEVAR vs Open Surgery for Complex Abdominal Aortic Aneurysm

The aim of the present study was to investigate outcomes of a propensity matched series of patients treated with F-BEVAR and open surgery repair for complex abdominal aortic aneurysm in two aortic high-volume centres.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aneurysm Aortic Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

This retrospective study analyzes the long-term outcomes of a propensity-matched cohort of patients with complex abdominal aortic aneurysm prospectively collected between January 2010 and June 2016 from the Aortic Center of Lille (Lille, France) and the Unit of Vascular Surgery of Policlinic Gemelli (Rome, Italy).

Patients were observed with regular postoperative appointments. The long-term imaging follow-up consisted in a yearly computed tomography angiography in the F-BEVAR group; and yearly abdominal ultrasound examination and 5-year computed tomography angiography were performed in the open surgery repair group. In case of abnormal renal function (eGFR<60 mL/min/1.73 m2), the patient underwent computed tomography without contrast associated to a contrast-enhanced ultrasound examination in both groups. Laboratory data with evaluation of renal function by estimated glomerular filtration rate (eGFR), were completed at three, six, and 12 months, and yearly thereafter. Survival assessment was completed after general partitioner's, patients' or patient siblings' contact by phone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • juxtarenal abdominal aortic aneurysms
  • pararenal abdominal aortic aneurysms
  • suprarenal abdominal aortic aneurysms
  • type IV thoracoabdominal aneurysms

Exclusion criteria

  • extent I to III thoracoabdominal aneurysms
  • ruptured o symptomatic aneurysms
  • dissections or connective tissue disorder aneurysms.

Treatment and study plan

Fenestrated and branched endovascular aortic repair (F-BEVAR)

Procedure

Fenestrated and branched endovascular aortic repair (F-BEVAR)

Open Repair

Procedure

Open surgery for complex abdominal aortic aneurysm

Primary outcomes

  1. Overall mortality

    Time frame: Through study completion, an average of 5 year

    All cause death

  2. Aortic-related mortality

    Time frame: Through study completion, an average of 5 year

    Any death related to the initial procedure.

  3. Chronic renal decline during follow-up

    Time frame: Through study completion, an average of 5 year

    Chronic renal decline was defined in patients with normal (stage 1-2) preoperative renal function as a reduction in the eGFR to <60 mL/min/1.73 m2 during follow-up. In patients with abnormal function (stages 3 and 4) preoperatively, it was defined as an eGFR reduction of >20% or de novo dependence on permanent renal replacement therapy.

Secondary outcomes

  1. Aortic-related reintervention

    Time frame: Through study completion, an average of 5 year

    All secondary interventions related to the initial procedure or to the endograft and its target vessels during follow-up

  2. Target vessel occlusion

    Time frame: Through study completion, an average of 5 year

    Complete obstruction of the artery with no evidence of flow identified on any follow-up CT scan or duplex ultrasound.

  3. Clinical failure

    Time frame: Through study completion, an average of 5 year

    Death from complications of the initial operation or a secondary intervention, aortic aneurysm rupture, aortic conversion to open surgical repair, persistent type I or III endoleak, sac expansion >5 mm, device migration >10mm, infection or thrombosis in the F-BEVAR group and death, graft infection or thrombosis or para-anastomotic aneurysm in the open group.

  4. Proximal aorta degeneration Proximal aorta degeneration

    Time frame: Through study completion, an average of 5 year

    Diameter increase >5 mm within 5 cm above the ostium of the more proximal target vessel for the endovascular group and 5 cm above the proximal anastomosis for the open group

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Centre Chirurgical Marie Lannelongue

Registry information

Official study title

Propensity Matched Comparison of Fenestrated Endovascular Aneurysm Repair and Open Surgical Repair for Complex Abdominal Aortic Aneurysms.

Important dates

Study start
2010
Primary completion
2018
Study completion
2022
First posted
Feb 21, 2022
Registry last updated
Feb 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.