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

NCT03985150 | Completed

• 1 other identifier: S62776
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Microstructural composition of diseased superficial femoral arterial tissue from histological analyses

  up to 3 years

• Microstructural composition of diseased superficial femoral arterial tissue from microCT analyses

  up to 3 years

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from peripheral arterial disease

You may qualify if:

• Patients suffering from critical ischemia in the lower limb and undergoing above-knee amputation

You may not qualify if:

• The presence of any feature that will prevent tissue collection after the amputation

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven campus Gasthuisberg

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The superficial femoral artery will be collected from the amputated limb

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 13, 2019
• Study Start: September 16, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: January 27, 2023

Record last verified: 2022-05

Locations

BE (1)