An observational study in Aneurysm Aortic and Vascular Diseases, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed. Per ClinicalTrials.gov, last updated 2022-02-21.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
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.
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's enrollment of 278 is above the median of 151 across 443 observational studies indexed under Aneurysm.
Browse Aneurysm studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
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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.
Exclusion Criteria:
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)
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
Fenestrated and branched endovascular aortic repair (F-BEVAR)
Open surgery for complex abdominal aortic aneurysm
Overall mortality
All cause death
Time frame: Through study completion, an average of 5 year
Aortic-related mortality
Any death related to the initial procedure.
Time frame: 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.
Time frame: Through study completion, an average of 5 year
Aortic-related reintervention
All secondary interventions related to the initial procedure or to the endograft and its target vessels during follow-up
Time frame: Through study completion, an average of 5 year
Target vessel occlusion
Complete obstruction of the artery with no evidence of flow identified on any follow-up CT scan or duplex ultrasound.
Time frame: Through study completion, an average of 5 year
Clinical failure
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.
Time frame: Through study completion, an average of 5 year
Proximal aorta degeneration Proximal aorta degeneration
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
Time frame: Through study completion, an average of 5 year
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS