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

NCT ID: NCT03985150

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-16
• Study Completion Date: 2022-09-30

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.

Conditions

Peripheral Arterial Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Biomechanical analysis of femoralis superficialis atherosclerotic tissue

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

Intervention Type: OTHER

CT or MR angiogram

Obtaining in vivo geometry of diseased artery

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven campus Gasthuisberg

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S62776

Identifier Type: -

Identifier Source: org_study_id