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

NCT05266781 | Completed

• 1 other identifier: PRO-ENDO TAAA study
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thoracoabdominal Aortic Aneurysms

Outcome Measures

Primary Outcomes (2)

• free survival

  1 year aortic-related and all cause mortality

  1 year

• aortic-related reintervention

  1 year clinical success

  1 year

Study Arms (2)

Open surgical repair

Aneurysmectomy and aortic reconstruction with a surgical graft

Procedure: Surgical repair

Endovascular repair

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

Procedure: Endovascular repair

Interventions

Surgical repair PROCEDURE

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

Open surgical repair

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)

Endovascular repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We aim to include at least 650 patients in a 3-month period. Follow-up data will be recorded up to 1 year postoperatively. Data verification and analysis will request 2 months after study completion. The overall duration of the study will be 6 months

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Related Publications (4)

• 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. doi: 10.1067/mva.1986.avs0030389.

  PMID: 3951025 BACKGROUND

• 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.

  PMID: 32089506 BACKGROUND

• 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.

  PMID: 31690525 BACKGROUND

• 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.

  PMID: 30470373 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Interventions

Wound Healing; Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: April 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)