Clinical trial NCT05247944: F-BEVAR vs Open Surgery for Complex Abdominal Aortic Aneurysm
Official title: Propensity Matched Comparison of Fenestrated Endovascular Aneurysm Repair and Open Surgical Repair for Complex Abdominal Aortic Aneurysms.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm Aortic
Vascular Diseases
Keywords: F-BEVAR
Open surgery
complex abdominal aortic aneurysm
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Centre Chirurgical Marie Lannelongue
First posted: 2022-02-21
Enrollment: 278
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall mortality
timeFrame: Through study completion, an average of 5 year
measure: Aortic-related mortality
timeFrame: Through study completion, an average of 5 year
measure: Chronic renal decline during follow-up
timeFrame: Through study completion, an average of 5 year
Secondary outcomes:
measure: Aortic-related reintervention
timeFrame: Through study completion, an average of 5 year
measure: Target vessel occlusion
timeFrame: Through study completion, an average of 5 year
measure: Clinical failure
timeFrame: Through study completion, an average of 5 year
measure: Proximal aorta degeneration Proximal aorta degeneration
timeFrame: Through study completion, an average of 5 year
Other outcomes:
Locations:
Study officials:
References:
citation: 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.