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

Thoracoabdominal Aortic Aneurysms Clinical Trial

— PRO-ENDO TAAA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05266781
• Other study ID #: PRO-ENDO TAAA study
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Aneurysm, Thoracic
• Thoracoabdominal Aortic Aneurysms

Intervention

Procedure:
• Surgical repair
Patients affected by a thoracoabdominal aortic aneurysm who received an open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft
• 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)

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Bertoglio L, Grandi A, Melloni A, Kahlberg A, Melissano G, Chiesa R. Percutaneous AXillary Artery (PAXA) Access at the First Segment During Fenestrated and Branched Endovascular Aortic Procedures. Eur J Vasc Endovasc Surg. 2020 Jun;59(6):929-938. doi: 10.1016/j.ejvs.2020.01.027. Epub 2020 Feb 20. — View Citation

Crawford ES, Crawford JL, Safi HJ, Coselli JS, Hess KR, Brooks B, Norton HJ, Glaeser DH. Thoracoabdominal aortic aneurysms: preoperative and intraoperative factors determining immediate and long-term results of operations in 605 patients. J Vasc Surg. 1986 Mar;3(3):389-404. — View Citation

Rocha RV, Friedrich JO, Elbatarny M, Yanagawa B, Al-Omran M, Forbes TL, Lindsay TF, Ouzounian M. A systematic review and meta-analysis of early outcomes after endovascular versus open repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2018 Dec;68(6):1936-1945.e5. doi: 10.1016/j.jvs.2018.08.147. — View Citation

Rocha RV, Lindsay TF, Friedrich JO, Shan S, Sinha S, Yanagawa B, Al-Omran M, Forbes TL, Ouzounian M. Systematic review of contemporary outcomes of endovascular and open thoracoabdominal aortic aneurysm repair. J Vasc Surg. 2020 Apr;71(4):1396-1412.e12. doi: 10.1016/j.jvs.2019.06.216. Epub 2019 Nov 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	free survival	1 year aortic-related and all cause mortality	1 year
Primary	aortic-related reintervention	1 year clinical success	1 year