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NCT Number: NCT07453251

Strength Tracking From Wall Tichness Over Aortic Biomechanics (STORM)

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Location status: Recruiting

Location contact

Alessandra Sala, MD

CONTACT

[email protected]

+39 0252774961

Alessandra Sala, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Primary outcomes

  1. Strength to rupture

    Time frame: During laboratory testing

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

Secondary outcomes

  1. Evaluate aortic characteristics

    Time frame: From surgery to laboratory testing

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

Other outcomes

  1. Standardize mechanical measurements

    Time frame: During laboratory testing

    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)

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Collaborators

  • University of Pavia

Registry information

Official study title

Strength Tracking From Wall Tichness Over Aortic Biomechanics

Acronym: STORM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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