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F-BEVAR vs Open Surgery for Complex Abdominal Aortic Aneurysm

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05247944
Enrollment
278
Registered
2022-02-21
Start date
2010-01-31
Completion date
2022-01-31
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm Aortic, Vascular Diseases

Keywords

F-BEVAR, Open surgery, complex abdominal aortic aneurysm

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.

Detailed description

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.

Interventions

PROCEDUREFenestrated and branched endovascular aortic repair (F-BEVAR)

Fenestrated and branched endovascular aortic repair (F-BEVAR)

PROCEDUREOpen repair

Open surgery for complex abdominal aortic aneurysm

Sponsors

Centre Chirurgical Marie Lannelongue
CollaboratorOTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall mortalityThrough study completion, an average of 5 yearAll cause death
Aortic-related mortalityThrough study completion, an average of 5 yearAny death related to the initial procedure.
Chronic renal decline during follow-upThrough study completion, an average of 5 yearChronic 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

MeasureTime frameDescription
Aortic-related reinterventionThrough study completion, an average of 5 yearAll secondary interventions related to the initial procedure or to the endograft and its target vessels during follow-up
Proximal aorta degeneration Proximal aorta degenerationThrough study completion, an average of 5 yearDiameter 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
Target vessel occlusionThrough study completion, an average of 5 yearComplete obstruction of the artery with no evidence of flow identified on any follow-up CT scan or duplex ultrasound.
Clinical failureThrough study completion, an average of 5 yearDeath 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026