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

IRCCS San Raffaele650 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

650

Conditions

Thoracoabdominal Aortic Aneurysms

Interventions

Surgical repairPROCEDURE

Patients affected by a thoracoabdominal aortic aneurysm who received an open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft

Endovascular repairPROCEDURE

Patients affected by a thoracoabdominal aortic aneurysm who received endovascular repair (with off-the-shelf or custom-made Fenestrated/Branched-Endovascular Aortic Repair - F/BEVAR)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

IRCCS Ospedale San Raffaele

Milan, Italy

Outcomes

Primary Outcomes

free survival

1 year aortic-related and all cause mortality

Time frame: 1 year

aortic-related reintervention

1 year clinical success

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.