"Percutaneous Axillary Access in the Endovascular Treatment of Thoracoabdominal Aortic Pathology" (PAXA)

NCT03223311 | Completed

• 1 other identifier: PAXA/31/OSR
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Since the development of custom-made fenestrated and branched endografts a novel therapeutic option for the management of thoracoabdominal and para-renal aortic aneurysms was made accessible. Because of the design of these branched endografts, an arterial vascular access from the upper limb is required to allow selective catheterization of the branch component and the respective target vessel (celiac trunk, superior mesenteric artery, renal artery).2

Conditions

Thoracoabdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Use of upper extremity access in endovascular repair of thoracoabdominal aortic aneurysms

  * Endovascular graft design : branched / fenestrated * Employment of UEA(upper extremity arterial access ) during TAAA endovascular repair: yes / no * Side of UEA(upper extremity arterial access ) cannulation (left / right) * Site of UEA(upper extremity arterial access ) cannulation:proximal axillary artery / distal axillary artery / upper brachial artery. * Size of percutaneuos access sheath employed measured in French - Fr * Number of percutaneuos access vessel closure devices employed * Access closure specific outcome: primary success / secondary success / failure As reported on patients' charts and operative report

  between 2013 and 2020

Secondary Outcomes (1)

• Upper extremity access vascular anatomy

  between 2013 and 2017.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient undergoing total endovascular treatment of thoracoabdominal pathology

You may qualify if:

• Patient undergoing total endovascular treatment of thoracoabdominal pathology at San Raffaele Hospital in between October 2013 and December 2020.

You may not qualify if:

• Incomplete imaging quality not including the arterial segments to be studied (axillary and brachial artery).

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, 20132, Italy

Location

Related Publications (4)

• Alvarez-Tostado JA, Moise MA, Bena JF, Pavkov ML, Greenberg RK, Clair DG, Kashyap VS. The brachial artery: a critical access for endovascular procedures. J Vasc Surg. 2009 Feb;49(2):378-85; discussion 385. doi: 10.1016/j.jvs.2008.09.017. Epub 2008 Nov 22.

  PMID: 19028057 RESULT

• Chuter TA, Rapp JH, Hiramoto JS, Schneider DB, Howell B, Reilly LM. Endovascular treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2008 Jan;47(1):6-16. doi: 10.1016/j.jvs.2007.08.032. Epub 2007 Nov 5.

  PMID: 17980540 RESULT

• 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 DERIVED

• Bertoglio L, Mascia D, Cambiaghi T, Kahlberg A, Melissano G, Chiesa R. Percutaneous axillary artery access for fenestrated and branched thoracoabdominal endovascular repair. J Vasc Surg. 2018 Jul;68(1):12-23. doi: 10.1016/j.jvs.2017.09.053. Epub 2018 Mar 1.

  PMID: 29503006 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

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

Study Officials

• Luca Bertoglio, MD

  SAn Raffaele Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 21, 2017
• Study Start: August 28, 2017
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)