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Completed

NCT Number: NCT03985150

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

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven campus Gasthuisberg

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biomechanical analysis of femoralis superficialis atherosclerotic tissue

Other

Tissue collection during above-knee amputation; mechanical testing of tissue; microstructural testing of tissue

CT or MR angiogram

Radiation

Obtaining in vivo geometry of diseased artery

Primary outcomes

  1. Biaxial stress-stretch curves of diseased superficial femoral arterial tissue from planar biaxial tension tests.

    Time frame: 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.

  2. Axial force and diameter curves in function of pressure from extension-inflation tests on diseased superficial femoral arterial tissue.

    Time frame: 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.

  3. Reaction force curves in function of indentation depth from indentation tests on diseased superficial femoral arterial tissue.

    Time frame: 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 outcomes

  1. Microstructural composition of diseased superficial femoral arterial tissue from histological analyses

    Time frame: up to 3 years

    Histological images will be analyzed to obtain the microstructural organization and composition of the collected tissue samples.

  2. Microstructural composition of diseased superficial femoral arterial tissue from microCT analyses

    Time frame: up to 3 years

    MicroCT images will be analyzed to obtain the microstructural organization and composition of the collected tissue samples.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Biomechanical Characterization of Atherosclerotic Arterial Tissue of the Femoralis Superficialis

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 13, 2019
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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