PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis

Study Overview
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Brief Summary
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Nowadays, stenting is became a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR). While most of local therapies have failed to demonstrate significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous transluminal angioplasty remains the current standard of care for this indication. Recent studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo lesions and of coronary ISR. FREERIDE, a French prospective cohort has been set up to evaluate the safety and the efficacy of drug eluting balloon (DEB) for the treatment of SFA atherosclerotic lesions.

Official Title
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PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: PacLitaxel Eluting Balloon Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old Symptomatic patient according to Rutherford Class 1, 2, 3, 4 or 5 Clinical degradation by at least 1 Rutherford stage or absence of healing of all skin lesions Symptoms related to SFA ISR defined by PSVR > 2.4 within 3 to 24 months after SFA stenting of de novo atherosclerotic lesions. Each patient may have either one or both limbs treated in the study The target ISR lesion is fully comprised between the origin of the SFA and distally the femoropopliteal crossover (crossing by SFA of medial rim of femur in the PA projection) Adequate SFA inflow and outflow either pre-existing or successfully re-established (outflow defined as patency of at least one infragenicular artery) The target lesion must no extend beyond the stent margin Successful crossing of the target lesion, inflow and outflow lesions with a guidewire Patient belongs to the French health care system Written informed consent Exclusion Criteria: No atheromatous disease Asymptomatic lesion Known allergies to heparin, aspirin, other anti-coagulant/antiplatelet therapies, and/or paclitaxel Acute limb ischemia Patient on oral anticoagulation therapy Target lesion requires / has been pre-treated with alternative therapy such as: DES, laser, atherectomy, cryoplasty, cutting/scoring balloon, etc. Life expectancy < 1 year Patient involved in another trial Refusing patient Pregnancy

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| drug eluting balloon<br>In this observationnal study, the intervention of interest is the use of drug eluting balloon in stent restenosis. Only the treated patients were included in this cohort. | Procedure: PacLitaxel Eluting Balloon Application<br>* Stenting is a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR). While most of local therapies have failed to demonstrate significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous transluminal angioplasty remains the current standard of care for this indication. Recent studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo lesions and of coronary ISR.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Revascularization (TLR) |  | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events through |  | at 1 year | 
| Target extremity revascularization (TER) |  | at 1, 3, 6, 9, 12 and 18 months after surgery | 
| clinical improvement equal or above to a stage according to Rutherford classification without superficial femoral artery revascularization | to assess primary maintenance of clinical improvement | at 1, 3, 6, 9, 12 and 18 months | 
| peak systolic velocity index without Target Lesion Revascularization | to assess primary patency | at 1, 3, 6, 9, 12 and 18 months | 
| Quality of life assessment by EQ5D questionnaire |  | at 1, 3, 6, 9, 12 and 18 mois after surgery | 
| post-angioplasty restenosis |  | at 1, 3, 6, 9, 12 and18 months after surgery | 
| drug relief success without balloon break |  | during surgery | 
| Length of hospitalization stay |  | at 1 year | 
| clinical improvement equal or above to a stage according to Rutherford classification with possible superficial femoral artery surgery | to assess secondary maintenance of clinical improvement | at 1, 3, 6, 9, 12 and 18 months | 
| peak systolic velocity index | to assess secondary patency | at 1 year | 
| intra-stent restenosis | significant whether restenosis >50% and peak systolic velocity index > 2.4 | at 1, 3, 6, 9, 12 and 18 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Superficial femoral artery, endovascular, Drug eluting balloon, Paclitaxel