F-BEVAR vs Open Surgery for Complex Abdominal Aortic Aneurysm

NCT05247944 | Completed

• 1 other identifier: 1843
• Study Type: observational
• Target: 278
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Aneurysm Aortic; Vascular Diseases

Keywords

F-BEVAR; Open surgery; complex abdominal aortic aneurysm

Outcome Measures

Primary Outcomes (3)

• Overall mortality

  All cause death

  Through study completion, an average of 5 year

• Aortic-related mortality

  Any death related to the initial procedure.

  Through study completion, an average of 5 year

• Chronic renal decline during follow-up

  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.

  Through study completion, an average of 5 year

Secondary Outcomes (4)

• Aortic-related reintervention

  Through study completion, an average of 5 year

• Target vessel occlusion

  Through study completion, an average of 5 year

• Clinical failure

  Through study completion, an average of 5 year

• Proximal aorta degeneration Proximal aorta degeneration

  Through study completion, an average of 5 year

Study Arms (2)

F-BEVAR

Patients with complex abdominal aortic aneurysm who underwent fenestrated and branched endovascular aortic repair (F-BEVAR) at the Aortic Center of Lille (ACL; Lille, France).

Procedure: Fenestrated and branched endovascular aortic repair (F-BEVAR)

OPEN SURGERY REPAIR

Patients with complex abdominal aortic aneurysm who underwent open surgery repair the Unit of Vascular Surgery of Policlinic Gemelli (FPUG; Rome, Italy).

Procedure: Open repair

Interventions

Fenestrated and branched endovascular aortic repair (F-BEVAR) PROCEDURE

Fenestrated and branched endovascular aortic repair (F-BEVAR)

F-BEVAR

Open repair PROCEDURE

Open surgery for complex abdominal aortic aneurysm

OPEN SURGERY REPAIR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 157 patients, referred to the Aortic Center of Lille (France), underwent F-BEVAR treatment; 119 patients, referred to the Policlinic Gemelli in Rome (Italy), concurrently underwent OSR.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Centre Chirurgical Marie Lannelongue: collaborator

Related Publications (1)

• 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

MeSH Terms

Conditions

Aortic Aneurysm; Vascular Diseases

Condition Hierarchy (Ancestors)

Aneurysm; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Endovascular Therapies Unit

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 21, 2022
• Study Start: January 1, 2010
• Primary Completion: January 31, 2018
• Study Completion: January 1, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share