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

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT03985150
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Study Timeline

• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-13
• Study Start: 2019-09-16
• Status Verified: 2022-05
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Patients suffering from critical ischemia in the lower limb and undergoing above-knee amputation

Exclusion Criteria

• The presence of any feature that will prevent tissue collection after the amputation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Axial force and diameter curves in function of pressure from extension-inflation tests on diseased superficial femoral arterial tissue.	up to 3 years	Extension-inflation tests will be performed on the collected tissue. The results of these tests, in the form of axial force and diameter curves, will be fitted to existing or to be developed constitutive models describing the mechanical behavior of arterial tissue.
Biaxial stress-stretch curves of diseased superficial femoral arterial tissue from planar biaxial tension tests.	up to 3 years	Planar biaxial tension tests will be performed on the collected tissue. The results of these tests, in the form of stress-stretch curves, will be fitted to existing or to be developed constitutive models describing the mechanical behavior of arterial tissue.
Reaction force curves in function of indentation depth from indentation tests on diseased superficial femoral arterial tissue.	up to 3 years	Indentation tests will be performed on the collected tissue. The results of these tests, in the form of reaction force versus indentation depth curves, will be fitted to existing or to be developed constitutive models describing the mechanical behavior of arterial tissue.

Secondary Outcome Measures

Name	Time	Method
Microstructural composition of diseased superficial femoral arterial tissue from histological analyses	up to 3 years	Histological images will be analyzed to obtain the microstructural organization and composition of the collected tissue samples.
Microstructural composition of diseased superficial femoral arterial tissue from microCT analyses	up to 3 years	MicroCT images will be analyzed to obtain the microstructural organization and composition of the collected tissue samples.

Trial Locations

Locations (1)

UZ Leuven campus Gasthuisberg; 🇧🇪 Leuven, Belgium