Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions

Study Overview
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Brief Summary
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This is a common care study. A study for evaluating the quality of balloon inflation and stent application will be performed in 2D angiography alone in the control group and then by 2D and OCT angiography for the experimental group. The benefit could be an improvement in the results of revascularization of femoropopliteal lesions thanks to OCT which allows a 3D visualization of the arterial lumen.

Official Title
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Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions

Conditions
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Superficial Femoral Artery Stenosis, Claudication, Ischemic Leg

Intervention / Treatment
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* Device: femoropopliteal revascularization for TASC C or TASC D lesion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over 18 years old Femoral-popliteal lesion TASC-C or TASC-D de novo (F1 to P1) Starting lesion on the superficial femoral artery and not extending beyond the intercondylar notch (P2) ≥1 continuous permeable leg axis directly injecting the plantar arch Rutherford 2-5 Exclusion Criteria: Patient under personal protection regime (tutorship, guardianship) Absence of arterial axis in permeable leg Patient presenting a limb acute ischaemia (chart evolving since less than 14 days) Patient without favorable element to consider healing History of stents on the femoropopliteal axis History of femoropopliteal bypass Untreated stenosis ≥30% on the iliac axis and common femoral upstream Popliteal lesion beyond the intercondylar notch (P2)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: angiography 2D<br>Control group: an arteriography will be performed on the entire treated segment to assess the quality of the result, the application or not an active balloon will be left to the discretion of the operator. In case of application of the active balloon, a new arteriography before decision or not the use of stenting will be practiced. In case of stenting, an arteriographic final is performed. | Device: femoropopliteal revascularization for TASC C or TASC D lesion<br>* Femoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control<br>|
| Experimental: angiography 2D with OCT<br>Experimental group: an arteriography and OCT acquisition on the entire treated segment to ensure the quality of the result, the application or not of an active ball will be left. In case of application of the active balloon, a new arteriography and OCT acquisition before decision or not the use of stenting will be practiced. In case of stenting, a final arteriography and then OCT acquisition are performed. | Device: femoropopliteal revascularization for TASC C or TASC D lesion<br>* Femoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency rate at 1 year. | The permeability rate is defined by the echodoppler criteria: PVS>2.4m/s or appearance of stenosis on the previously treated segment >70%. | at 12 months (+/- 2months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency rate at 1 year. |  | at 1month (+/- 10days), 6months (+/- 1month) | 
| Target lesion revascularisation | corresponds to the occurrence of a re-intervention on the treated segment to maintain or restore permeability | at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months) | 
| Target vessel revascularisation | corresponds to the occurrence of a re-intervention on the previously treated artery, whatever the level, in order to maintain its permeability. | at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months) | 
| cost-effectiveness analyses | Cost-effectiveness analysis between 2 therapeutic strategies: The costs related to each strategy are calculated taking into account the direct and indirect costs. | at 12 months (+/- 2months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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femoral recanalization, optical coherence tomography (OCT), endovascular treatment, TASC-C,, TASC-D