Evaluation of STaged Endovascular Aneurysm Repair in the Management of Thoracoabdominal Pathology by Means of Branched and Fenestrated Devices.(STEAR)

NCT03342755 | Completed

• 1 other identifier: STEAR/33/OSR
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to analyzing the impact of the staged endovascular treatment (divided into two or more distinct procedures) of thoracoabdominal aneurysmatic pathology on short and medium term, technical and clinical outcomes and on the possible benefits or complications associated with this approach.

Conditions

Thoracoabdominal Aneurysm

Outcome Measures

Primary Outcomes (3)

• Prevention of rupture of aortic aneurysm or other aortic pathology

  between October 2013 and December 2020

• Prevention of death from aneurysm rupture or other aortic pathology (including end-organ ischemia)

  between October 2013 and December 2020

• Prevention of death associated with primary or secondary treatment of the original aortic pathology, including operative or endovascular intervention for rupture, dissection, or end-organ ischemia

  between October 2013 and December 2020

Secondary Outcomes (3)

• New, expanding, or progressing: aneurysm, dissection, ulceration, or hematoma

  between October 2013 and December 2020

• Device migration,degradation (eg, stent fracture, fabric erosion);

  between October 2013 and December 2020

• Endoleak presence (for aneurysm),Endoleak requiring intervention

  between October 2013 and December 2020

Eligibility Criteria

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

Study Population

patients undergoing total endovascular treatment of thoracoabdominal pathology (single-stage or multi-stage endovascular repair) at San Raffaele Hospital in between October 2013 and December 2020

You may qualify if:

• patient with ≥ 18 years of age, undergoing total endovascular treatment of thoracoabdominal pathology (single-stage or multi-stage endovascular repair) at San Raffaele Hospital in between October 2013 and December 2020.

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, 20132, Italy

Location

Related Publications (3)

• O'Callaghan A, Mastracci TM, Eagleton MJ. Staged endovascular repair of thoracoabdominal aortic aneurysms limits incidence and severity of spinal cord ischemia. J Vasc Surg. 2015 Feb;61(2):347-354.e1. doi: 10.1016/j.jvs.2014.09.011. Epub 2014 Oct 23.

  PMID: 25449006 BACKGROUND

• 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 BACKGROUND

• Fillinger MF, Greenberg RK, McKinsey JF, Chaikof EL; Society for Vascular Surgery Ad Hoc Committee on TEVAR Reporting Standards. Reporting standards for thoracic endovascular aortic repair (TEVAR). J Vasc Surg. 2010 Oct;52(4):1022-33, 1033.e15. doi: 10.1016/j.jvs.2010.07.008. No abstract available.

  PMID: 20888533 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: November 21, 2017
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)