Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 4:47 AM
Study NCT ID:
NCT07453251
Status:
RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strength Tracking From Wall Tichness Over Aortic Biomechanics (STORM)
Sponsor:
IRCCS Policlinico S. Donato
Organization:
Study Overview
Official Title:
Strength Tracking From Wall Tichness Over Aortic Biomechanics
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STORM
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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: