Clinical trial NCT03985150: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from peripheral arterial disease

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.

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

Primary outcomes:
measure: Biaxial stress-stretch curves of diseased superficial femoral arterial tissue from planar biaxial tension tests.
timeFrame: up to 3 years
measure: Axial force and diameter curves in function of pressure from extension-inflation tests on diseased superficial femoral arterial tissue.
timeFrame: up to 3 years
measure: Reaction force curves in function of indentation depth from indentation tests on diseased superficial femoral arterial tissue.
timeFrame: up to 3 years
Secondary outcomes:
measure: Microstructural composition of diseased superficial femoral arterial tissue from histological analyses
timeFrame: up to 3 years
measure: Microstructural composition of diseased superficial femoral arterial tissue from microCT analyses
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven campus Gasthuisberg
Study officials:
References: