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出境医 / 临床实验 / Biomechanical Analysis of Arterial Tissue From Patient Suffering From Peripheral Artery Disease in the Lower Limb

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

Study Description
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.

Study Design
Layout table for study information
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
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022
Arms and Interventions
Outcome Measures
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

Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 27, 2019
First Posted Date June 13, 2019
Last Update Posted Date November 13, 2020
Actual Study Start Date September 16, 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 12, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomechanical Analysis of Arterial Tissue From Patient Suffering From Peripheral Artery Disease in the Lower Limb
Official Title Biomechanical Characterization of Atherosclerotic Arterial Tissue of the Femoralis Superficialis
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
The superficial femoral artery will be collected from the amputated limb
Sampling Method Non-Probability Sample
Study Population Patients suffering from peripheral arterial disease
Condition Peripheral Arterial Disease
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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: June 12, 2019) 		38
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT03985150
Other Study ID Numbers S62776
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Universitaire Ziekenhuizen Leuven
Study Sponsor Universitaire Ziekenhuizen Leuven
Collaborators Not Provided
Investigators Not Provided
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date November 2020

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