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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Thoracoabdominal Aortic Aneurysms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Open surgical repair

Aneurysmectomy and aortic reconstruction with a surgical graft

Surgical repair

Intervention Type PROCEDURE

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

Endovascular repair

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

Endovascular repair

Intervention Type 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)

Interventions

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Surgical repair

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

Intervention Type PROCEDURE

Endovascular repair

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)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No