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Completed

NCT Number: NCT05266781

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical repair

Procedure

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

Endovascular repair

Procedure

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)

Primary outcomes

  1. free survival

    Time frame: 1 year

    1 year aortic-related and all cause mortality

  2. aortic-related reintervention

    Time frame: 1 year

    1 year clinical success

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

A PROpensity Score Matching Analysis on ENDovascular vs Open Thoraco-Abdominal Aortic Aneurysm Repair . A Single-center, Retrospective-prospective, Observational Study/ EUnetHTA Core Model

Acronym: PRO-ENDO TAAA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2022
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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