Artery StenosisBEHAVIORNCT06113172
Behavior of the Iliofemoral Segment
A study testing Hip flexion in people with Artery Stenosis, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Artery Stenosis
- What is being tested?
- Hip flexion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2023to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Artery Stenosis
- Being tested
- Hip flexion
- Keywords
- iliofemoral segment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip flexionOther
during the delay phase, the patients are asked to bend their knee in order to achieve the maximum degree of hip flexion
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Patients 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. In case of difference of calcifications between both CFA, the CFA with less calcifications will be chosen for analysis. Receives: Other: Hip flexion |
| Stent | Other | Patients referred for endovascular stenting of the common femoral artery with and indication of CTA before the surgery. For these patient a CTA will be performed 1 month before and 1 month after surgery Receives: Other: Hip flexion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6months
Secondary outcomes (4)
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.
Measured: 6 months
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).
Measured: 6months
Analysis of the internal and kinetic energy
- Kinematic and internal energy (N*m) along the ROI (maximum and minimum values and localization).
Measured: 6months
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.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start15 Nov 2023 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113172
- Sponsor's protocol ID
- 651
- Acronym
- BEHAVIOR
- Status last verified
- Oct 2023
- First submitted
- 27 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior of the Iliofemoral Segment
- ClinicalTrials.gov ID
- NCT06113172
- Acronym / sponsor ID
- BEHAVIOR / 651
- Conditions
- Artery Stenosis
- Keywords
- iliofemoral segment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Hip flexionPatients 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. In case of difference of calcifications between both CFA, the CFA with less calcifications will be chosen for analysis. |
| Stent | Other | Other: Hip flexionPatients referred for endovascular stenting of the common femoral artery with and indication of CTA before the surgery. For these patient a CTA will be performed 1 month before and 1 month after surgery |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip flexionduring the delay phase, the patients are asked to bend their knee in order to achieve the maximum degree of hip flexion | Other | Control, Stent |
Primary outcome
deformation and stress
Time frame: 6months
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.
4 secondary outcomes
anatomical variations of the artery
Time frame: 6 months
Evaluation of the mechanical forces
Time frame: 6months
Analysis of the internal and kinetic energy
Time frame: 6months
Evaluation of the risk of stent fracture
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip flexion in people with Artery Stenosis, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hélène BEAUSSIER, pharmaD, phD (+33144127038, hbeaussier@ghspj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
deformation and stress (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.