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

Peripheral Arterial Disease Clinical Trial

Official title:

Biomechanical Characterization of Atherosclerotic Arterial Tissue of the Femoralis Superficialis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985150
• Other study ID #: S62776
• Status: Completed
• Start date: September 16, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Leuven campus Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biaxial stress-stretch curves of diseased superficial femoral arterial tissue from planar biaxial tension tests.	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.	up to 3 years
Primary	Axial force and diameter curves in function of pressure from extension-inflation tests on diseased superficial femoral arterial tissue.	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.	up to 3 years
Primary	Reaction force curves in function of indentation depth from indentation tests on diseased superficial femoral arterial tissue.	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.	up to 3 years
Secondary	Microstructural composition of diseased superficial femoral arterial tissue from histological analyses	Histological images will be analyzed to obtain the microstructural organization and composition of the collected tissue samples.	up to 3 years
Secondary	Microstructural composition of diseased superficial femoral arterial tissue from microCT analyses	MicroCT images will be analyzed to obtain the microstructural organization and composition of the collected tissue samples.	up to 3 years