Behavior of the Iliofemoral Segment

Artery Stenosis Clinical Trial

— BEHAVIOR  

Official title:

Behavior of the Iliofemoral Segment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06113172
• Other study ID #: 651
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: October 2023
• Source: Fondation Hôpital Saint-Joseph
• Contact: Hélène BEAUSSIER, pharmaD, phD
• Phone: +33144127038
• Email: hbeaussier[@]ghspj.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Peripheral artery diseases (PAD) are associated with an overall increased risk of mortality and morbidity, as a consequence of fatal or non-fatal vascular events, mainly due to the total or partial occlusion of the affected artery. Particularly, lower extremity occlusive arterial diseases remain a global concern, affecting more than 200 million people worldwide in 2015. Regarding the iliofemoral segment and, especially, the common femoral artery (CFA), conventional surgical approach (namely common femoral endarterectomy, CFE) is still as the gold standard despite its high morbidity rates mainly due to high rate of wound sepsis and autonomy loss . Endovascular procedures with CFA stenting have been introduced as a promising alternative for their multiple advantages such as shorter hospital stay and less perioperative complications. However, its acceptance among the vascular surgery community has been limited.

Endovascular stenting aims to reduce restenosis and improve the target lesion revascularization rates by the implementation of the stent at the level of the CFA. Nevertheless, fear of stent fracture due to hip mobility constitutes one of the main limitations to its implantation, despite the lack of widely accepted quantitative evidence of their relationship. Thus, this study aims to validate that the stresses and deformations on the iliofemoral segment during hip flexion are not a direct cause of stent fracture.

Numerical 3D models offer a non-invasive, inexpensive and personalized approach in the biomedical engineering field; thereby encouraging their use for the biomechanical study of different anatomical structures. These models are able to simulate the behavior and, additionally, quantify the forces, stresses and deformations of different organs and systems by implementing the information gathered in clinical measurements, diagnostic tests and imaging. 3D models can be reconstructed from computed tomography scans (CT scans). Specifically, CT angiography (CTA) images, offering high-quality and high-contrast images, facilitate the creation of numerical models of the vascular system (including the iliofemoral segment).

Our study will analyze the mechanical behavior of the iliofemoral segment by the creation of a numerical simulation to estimate the stresses and deformations at the level of the CFA during hip flexion. For this purpose, our project aims to use 3D models of this region reconstructed CT scans that are routinely performed preoperatively for PAD patients. Indeed CT scan are indicated for anatomical characterization of PAD lesions and guidance for optimal revascularization therapy.

The results of this study could be applied to the assessment of the treatment of lower extremities occlusive arterial diseases at the level of the CFA.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patient's age > 65 years old

• Patient with Glomerular filtration rate > 60ml/mn

• Patient affiliated to the French Health insurance system

• Patient with a preoperative duplex scan of the lower limbs

• Patient with an indication of CT scan with either diagnostic or preoperative purposes

• Patient referred for endovascular procedure (aortic or peripheral), with an indication of CTA comprising the CFA region, without significant lesions of the external iliac and common femoral arteries (control group) or patients referred for endovascular stenting of the common femoral artery (stent group)

Exclusion Criteria:

• Patient with significant below the knee arterial lesions according the duplex scan analysis

• Hip arthroplasty.

• Hip pain and stiffness caused by hip arthritis.

• Patient under guardianship

• Patient deprived of liberty

• Patient under court protection

• Patient objecting to the use of his/her data for this research

Related Conditions & MeSH terms

• Artery Stenosis

Intervention

Other:
• Hip flexion
during the delay phase, the patients are asked to bend their knee in order to achieve the maximum degree of hip flexion

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Hôpital Saint-Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	deformation and stress	a composite outcome will be used to describe both deformation and mechanical stresses from minimum to maximum hip flexion. It will comprise: Variation of lumen diameter (in mm and percentage) and length of the ROI (mm).; Angulation (°) and maximum inscribed sphere (MIS) diameter (mm) at the bending points normalized by the degree of hip flexion as described in Figure 1A.; Variation of the strain (%).; Variation shear stresses (in mPa).; Variation of Von Mises stress and ,1st and 3rd principal stresses Each of these elements will be calculated at the level of the Region of Interest (ROI) measured by numerical simulation. The ROI covers the arterial segment between the section located 2cm above the inguinal ligament (end of external iliac artery) to the section located 3 cm above the crossing with the sartorius for the superficial femoral artery and 1cm above the CFA bifurcation for the deep femoral artery.	6months
Secondary	anatomical variations of the artery	Variation of lumen diameter (in mm and percentage) and length of the ROI (mm).; Angulation (°) and maximum inscribed sphere (MIS) diameter (mm) at the bending points.	6 months
Secondary	Evaluation of the mechanical forces	Cross-sectional forces over the centerline of the ROI (Newtons) and bending moments (Newton x meter); Resultant forces at contact interfaces along the ROI and boundary forces (Newtons).	6months
Secondary	Analysis of the internal and kinetic energy	- Kinematic and internal energy (N*m) along the ROI (maximum and minimum values and localization).	6months
Secondary	Evaluation of the risk of stent fracture	Strain (%), shear stresses, von Mises stress and ,1st and 3rd principal stresses at the stent; Variation of stent's diameter (in mm and percentage) and length (mm).; Angulation (°) and maximum inscribed sphere (MIS) diameter (mm) at the bending points of the stent.	6months