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

San Donato Group (GSD)

Status: Completed

Conditions: Thoracoabdominal Aortic Aneurysms

Treatments: Procedure: Endovascular repair; Procedure: Surgical repair

Study type: Observational

Funder types: Other

Identifiers

NCT05266781

PRO-ENDO TAAA study

Details and patient eligibility

About

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

Full 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.

Enrollment: 650 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

650 participants in 2 patient groups

Open surgical repair

Description:

Aneurysmectomy and aortic reconstruction with a surgical graft

Treatment:

Procedure: Surgical repair

Endovascular repair

Description:

Off-the-shelf or custom-made Fenestrated/Branched-Endovascular Aortic Repair - F/BEVAR

Treatment:

Procedure: Endovascular repair