NCT03985150

Biomechanical Analysis of Arterial Tissue From Patient Suffering From Peripheral Artery Disease in the Lower Limb

Biomechanical Characterization of Atherosclerotic Arterial Tissue of the Femoralis Superficialis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current treatment approaches for peripheral artery disease are largely unsatisfactory. Therefore, diseased tissue will be collected as well as patient-specific arterial geometries. The tissue will be tested microstructurally and mechanically to obtain data required to optimize treatment methods through in silico modeling.

Detailed description

Peripheral artery disease (PAD) is a severe cause of morbidity in patients. Common treatment approaches are too often still unsatisfactory. Angioplasty is commonly followed by restenosis, caused by overloading of the arterial tissue. This study is aimed at improving this treatment approach through the in silico simulation of arterial remodeling after balloon expansion. Such simulations require the input of a patient-specific geometry and the mechanical properties of (diseased) arterial tissue. Patients scheduled for an above knee lower limb amputation due to critical ischemia will be recruited in this study. After the surgery, the femoralis superficialis will be collected, as well as the CT or MR angiogram obtained before the surgery. The arterial tissue will be mechanically tested to obtain material properties and the medical image will be used to determine the arterial geometry. A correlation study will be carried out to explore the possibility of including a predictive simulation of the restenosis outcome of balloon angioplasty in the clinical practice.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
OTHER	Biomechanical analysis of femoralis superficialis atherosclerotic tissue	Tissue collection during above-knee amputation; mechanical testing of tissue; microstructural testing of tissue
RADIATION	CT or MR angiogram	Obtaining in vivo geometry of diseased artery

Timeline

• Start date: 2019-09-16
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2019-06-13
• Last updated: 2023-01-27

Locations

1 site across 1 country: Belgium