Aneurysm AorticSTORMNCT07453251
Strength Tracking From Wall Tichness Over Aortic Biomechanics (STORM)
An observational study of Aneurysm Aortic and Aneurysm Aortic Root, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm Aortic, Aneurysm Aortic Root
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 25 Oct 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery for ascending or aortic root aneurysms.
Who may be able to join
- 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.
Who cannot join
- Patients that have already undergone previous cardiac surgery; • Patients that present with acute aortic pathologies, such as acute aortic dissection or intramural hematoma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, MI, 20097
Alessandra Sala, MD, +39 0252774961, alessandra.sala@grupposandonato.it
Alessandra Sala, MD
About this study
Official title: Strength Tracking From Wall Tichness Over Aortic Biomechanics
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.
- Conditions
- Aneurysm Aortic, Aneurysm Aortic Root
- Keywords
- aortic aneurysm, bicuspid aortic valve, tricuspid aortic valve, tensile testing, aortic strength, aortic rupture
- Medical subject headings
- Aortic Aneurysm, Aortic Root Aneurysm, Bicuspid Aortic Valve Disease, Aortic Rupture
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From surgery to laboratory testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start25 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Aneurysm AorticStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia
- Responsible party
- Principal investigator, Alessandra Sala, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453251
- Sponsor's protocol ID
- CET 316-2025
- Acronym
- STORM
- Status last verified
- Feb 2026
- First submitted
- 2 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the investigators not planning to share IPD, because anonymised data might be used for future scientific publications
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 26356765Khanafer 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 21616506Vorp 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 12683565Surman 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 34496896Dong 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 35134955Plonek 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Tracking From Wall Tichness Over Aortic Biomechanics
- ClinicalTrials.gov ID
- NCT07453251
- Acronym / sponsor ID
- STORM / CET 316-2025
- Conditions
- Aneurysm Aortic, Aneurysm Aortic Root
- Keywords
- aortic aneurysm, bicuspid aortic valve, tricuspid aortic valve, tensile testing, aortic strength, aortic rupture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Collaborators
- University of Pavia
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery for ascending or aortic root aneurysms.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients that have already undergone previous cardiac surgery; • Patients that present with acute aortic pathologies, such as acute aortic dissection or intramural hematoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Evaluate aortic characteristics
Time frame: From surgery to laboratory testing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Results publication: PubMed 26356765Ferrara 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.
- Results publication: PubMed 21616506Khanafer 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.
- Results publication: PubMed 12683565Vorp 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.
- Results publication: PubMed 34496896Surman 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.
- Results publication: PubMed 35134955Dong 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.
- Results publication: PubMed 29262774Plonek 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.
- Individual participant dataSharing planned: No. the investigators not planning to share IPD, because anonymised data might be used for future scientific publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
IRCCS Policlinico San Donato
San Donato Milanese, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm Aortic and Aneurysm Aortic Root, run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength to rupture (time frame: During laboratory testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07453251, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.