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RecruitingNCT07453251STORMUpdated Mar 11, 2026

Strength Tracking From Wall Tichness Over Aortic Biomechanics (STORM)

An observational study in Aneurysm Aortic and Aneurysm Aortic Root, sponsored by IRCCS Policlinico S. Donato. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by IRCCS Policlinico S. Donato · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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).

Read the detailed description

The aortic wall is subjected to mechanical stresses in radial, circumferential, and longitudinal directions. The amount of these shear stresses varies with the distribution of velocity across the vessel lumen and with local vessel geometry.

Diseases affecting the thoracic aorta can be categorized into acute and chronic. Chronic aortic pathologies are chronic aortic dissections and aortic aneurysms.

Today, there are computational tools available to permit the calculation of stresses of the aortic wall.

For the above-mentioned reasons, this study becomes of extreme interest as it may be capable of further assessing the mechanical properties of the dilated aortic tissue, its' strength to rupture and stiffness, in order to provide an overview of the fragility of ascending aortic aneurysms. This parameter, associated to the diameter of the pathological aorta, may provide an additional tool regarding the clinical history of patients and insight concerning surgical indication.

Matter of factly, knowing the risk of rupture based on diameter may have strong implications on the preoperative evaluation of patients and the decision-making process.

02

Conditions studied

  • Aneurysm Aortic
  • Aneurysm Aortic Root

Keywords

  • aortic aneurysm
  • bicuspid aortic valve
  • tricuspid aortic valve
  • tensile testing
  • aortic strength
  • aortic rupture
03

In context

Aortic Aneurysm

222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.

This study's planned enrollment of 40 is below the median of 150 across 117 observational studies indexed under Aortic Aneurysm.

Browse Aortic Aneurysm studies →

Lead sponsor

IRCCS Policlinico S. Donato is the lead sponsor of 103 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing cardiac surgery for ascending or aortic root aneurysms.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients that have already undergone previous cardiac surgery; • Patients that present with acute aortic pathologies, such as acute aortic dissection or intramural hematoma.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

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.

    Time frame: During laboratory testing

Secondary outcomes

  1. Evaluate aortic characteristics

    Evaluate multiple characteristics of the surgically excised pathologically enlarged aortic segments: shape alteration, tensile strength, elasticity capacity.

    Time frame: From surgery to laboratory testing

Other outcomes

  1. Standardize mechanical measurements

    Assess from a methodological point of view the various aspects and results of the different test and identify the ideal testing method (uniaxial vs biaxial)

    Time frame: During laboratory testing

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 26356765 ↗
  • 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. PubMed 21616506 ↗
  • 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. PubMed 12683565 ↗
  • 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. PubMed 34496896 ↗
  • 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. PubMed 35134955 ↗
  • 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. PubMed 29262774 ↗

Individual participant data

Plan to share: No — the investigators not planning to share IPD, because anonymised data might be used for future scientific publications

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07453251
Collaborators
University of Pavia
Responsible party
Alessandra Sala (Cardiac Surgeon, IRCCS Policlinico S. Donato) — Principal investigator
First posted
Mar 5, 2026
Start date
Oct 25, 2025
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Mar 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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