F-BEVAR vs Open Surgery for Complex Abdominal Aortic Aneurysm

Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05247944
• Other study ID #: 1843
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Aortic
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Vascular Diseases

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