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

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ClinicalTrials.gov Identifier: NCT03985150
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen 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.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Other: Biomechanical analysis of femoralis superficialis atherosclerotic tissue Radiation: CT or MR angiogram

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.


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Study Type : Observational
Estimated Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomechanical Characterization of Atherosclerotic Arterial Tissue of the Femoralis Superficialis
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
The superficial femoral artery will be collected from the amputated limb


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from peripheral arterial disease
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985150


Contacts
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Contact: Nele Famaey, PhD +32 16 32 89 80 nele.famaey@kuleuven.be
Contact: Lauranne Maes, MSc +32 16 19 31 34 lauranne.maes@kuleuven.be

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03985150     History of Changes
Other Study ID Numbers: S62776
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases