A PROpensity Score Matching Analysis on ENDovascular vs Open Thoraco-Abdominal Aortic Aneurysm Repair (PRO-ENDO TAAA Study)

Completed

• Conditions: Thoracoabdominal Aortic Aneurysms
• Interventions: Procedure: Endovascular repair; Procedure: Surgical repair

• Registration Number: NCT05266781
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

The purpose of the registry is to compare the surgical and endovascular approaches to the treatment of thoracoabdominal aortic aneurysms.

Detailed Description

The purpose of the study is to compare the surgical and endovascular approaches to the treatment of thoracoabdominal aortic aneurysms. In particular, the study aims at comparing the short- and mid-term mortality, morbidity and reintervention rate after open surgery or endovascular repair of thoracoabdominal aortic aneurysms in comparable cohorts of patients according to preoperative characteristics and evaluating the cost-effectiveness of both techniques, according to the EUnetHTA core model.

The study results will contribute to the creation of a HTA Report regarding endovascular technology to treat thoracoabdominal aortic aneurysms which will be evaluated by the appropriate Health Authorities.

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-03-04
• Study Start: 2022-04-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

• Patients affected by a thoracoabdominal aortic aneurysm who received an open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft) or endovascular repair (with off-the-shelf or custom-made Fenestrated/Branched-Endovascular Aortic Repair - F/BEVAR) between January 2013 and June 2021 at San Raffaele Hospital (Vascular Surgery Unit)
• Adult patients ≥18 years
• The patient is able to understand and sign the informed consent approved by the Ethics Committee of the San Raffaele Hospital

Exclusion Criteria

• Patients treated with a hybrid approach (open surgical retrograde revascularization of renovisceral arteries followed by aneurysm exclusion with endograft)
• Patients treated with other endovascular techniques besides fenestrated or branched technology (e.g., physician-modified endografts, parallel grafts).
• Patients with a juxtarenal or pararenal aortic aneurysm
• Patients treated with F/BEVAR for a visceral artery patch aneurysm after open thoracoabdominal repair

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endovascular repair	Endovascular repair	Off-the-shelf or custom-made Fenestrated/Branched-Endovascular Aortic Repair - F/BEVAR
Open surgical repair	Surgical repair	Aneurysmectomy and aortic reconstruction with a surgical graft

Primary Outcome Measures

Name	Time	Method
free survival	1 year	1 year aortic-related and all cause mortality
aortic-related reintervention	1 year	1 year clinical success

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy