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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05247944
Other study ID # 1843
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2010
Est. completion date January 2022

Study information

Verified date February 2022
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 278
Est. completion date January 2022
Est. primary completion date January 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Procedure:
Fenestrated and branched endovascular aortic repair (F-BEVAR)
Fenestrated and branched endovascular aortic repair (F-BEVAR)
Open repair
Open surgery for complex abdominal aortic aneurysm

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Centre Chirurgical Marie Lannelongue

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall mortality All cause death Through study completion, an average of 5 year
Primary Aortic-related mortality Any death related to the initial procedure. Through study completion, an average of 5 year
Primary 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 Aortic-related reintervention All secondary interventions related to the initial procedure or to the endograft and its target vessels during follow-up Through study completion, an average of 5 year
Secondary Target vessel occlusion Complete obstruction of the artery with no evidence of flow identified on any follow-up CT scan or duplex ultrasound. Through study completion, an average of 5 year
Secondary 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. Through study completion, an average of 5 year
Secondary 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 Through study completion, an average of 5 year
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