Strength Tracking From Wall Tichness Over Aortic Biomechanics (STORM)

NCT07453251 | Recruiting

• 1 other identifier: CET 316-2025
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to analyse the resected portion of aneurysmatic ascending aorta in order to assess its strength to rupture, standardise the various measurements performed within the lab and try to correlate these qualitative results with quantitative results (regarding aortic diameter, valve morphology and aortic wall thickness).

Conditions

Aneurysm Aortic; Aneurysm Aortic Root

Keywords

aortic aneurysm; bicuspid aortic valve; tricuspid aortic valve; tensile testing; aortic strength; aortic rupture

Outcome Measures

Primary Outcomes (1)

• Strength to rupture

  Define the strength to rupture of the removed aortic segments and its relation with the circumferential and longitudinal direction along the aortic axis.

  During laboratory testing

Secondary Outcomes (1)

• Evaluate aortic characteristics

  From surgery to laboratory testing

Other Outcomes (1)

• Standardize mechanical measurements

  During laboratory testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiac surgery for ascending or aortic root aneurysms.

You may qualify if:

• Patients undergoing cardiac surgery for either aortic root and/or ascending aortic aneurysms; • Patients that have received, understood and signed the written informed consent for this study.

You may not qualify if:

• Patients that have already undergone previous cardiac surgery; • Patients that present with acute aortic pathologies, such as acute aortic dissection or intramural hematoma.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead
• University of Pavia: collaborator

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

RECRUITING

Related Publications (6)

• Ferrara A, Morganti S, Totaro P, Mazzola A, Auricchio F. Human dilated ascending aorta: Mechanical characterization via uniaxial tensile tests. J Mech Behav Biomed Mater. 2016 Jan;53:257-271. doi: 10.1016/j.jmbbm.2015.08.021. Epub 2015 Aug 20.

  PMID: 26356765 RESULT

• Khanafer K, Duprey A, Zainal M, Schlicht M, Williams D, Berguer R. Determination of the elastic modulus of ascending thoracic aortic aneurysm at different ranges of pressure using uniaxial tensile testing. J Thorac Cardiovasc Surg. 2011 Sep;142(3):682-6. doi: 10.1016/j.jtcvs.2010.09.068. Epub 2011 May 25.

  PMID: 21616506 RESULT

• Vorp DA, Schiro BJ, Ehrlich MP, Juvonen TS, Ergin MA, Griffith BP. Effect of aneurysm on the tensile strength and biomechanical behavior of the ascending thoracic aorta. Ann Thorac Surg. 2003 Apr;75(4):1210-4. doi: 10.1016/s0003-4975(02)04711-2.

  PMID: 12683565 RESULT

• Surman TL, Abrahams JM, Manavis J, Finnie J, O'Rourke D, Reynolds KJ, Edwards J, Worthington MG, Beltrame J. Histological regional analysis of the aortic root and thoracic ascending aorta: a complete analysis of aneurysms from root to arch. J Cardiothorac Surg. 2021 Sep 8;16(1):255. doi: 10.1186/s13019-021-01641-5.

  PMID: 34496896 RESULT

• Dong H, Liu M, Qin T, Liang L, Ziganshin B, Ellauzi H, Zafar M, Jang S, Elefteriades J, Sun W. Engineering analysis of aortic wall stress and root dilatation in the V-shape surgery for treatment of ascending aortic aneurysms. Interact Cardiovasc Thorac Surg. 2022 Jun 1;34(6):1124-1131. doi: 10.1093/icvts/ivac004.

  PMID: 35134955 RESULT

• Plonek T, Zak M, Burzynska K, Rylski B, Gozdzik A, Kustrzycki W, Beyersdorf F, Jasinski M, Filipiak J. The combined impact of mechanical factors on the wall stress of the human ascending aorta - a finite elements study. BMC Cardiovasc Disord. 2017 Dec 20;17(1):297. doi: 10.1186/s12872-017-0733-9.

  PMID: 29262774 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Resected aneurysmal aortic segment

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Root Aneurysm; Bicuspid Aortic Valve Disease; Aortic Rupture

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Aneurysm, Thoracic; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aneurysm, Ruptured; Rupture; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Surgeon

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 5, 2026
• Study Start: October 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)