Clinical Trials Directory

Trials / Completed

CompletedNCT05247944

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
Phase
Study type
Observational
Enrollment
278 (actual)
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREFenestrated and branched endovascular aortic repair (F-BEVAR)Fenestrated and branched endovascular aortic repair (F-BEVAR)
PROCEDUREOpen repairOpen surgery for complex abdominal aortic aneurysm

Timeline

Start date
2010-01-01
Primary completion
2018-01-31
Completion
2022-01-01
First posted
2022-02-21
Last updated
2022-02-21

Source: ClinicalTrials.gov record NCT05247944. Inclusion in this directory is not an endorsement.