BEnefit of Arterial Preparation by LONGitudinal Scoring

Study Overview
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Brief Summary
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The purpose of the artery preparation concept is to perform regular longitudinal micro-incisions on the inner side of the artery (scoring) and therefore promote a regular expansion of atheroma by balloon inflation.

Official Title
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BEnefit of Arterial Preparation by LONGitudinal Scoring Before Paclitaxel Eluting Balloon Angioplasty of the Superficial Femoral and Popliteal Artery

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: FLEX Scoring Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18-year-old, with symptomatic lower extremity occlusive arterial disease Rutherford class of symptom 2 to 5 Atheromatous ≥ 70 % stenosis or occlusion of SFA and/or PA Absence of > 50% residual stenosis of the run-in vessels at the end of procedure Presence of at least one patent (no ≥ 50 % stenosis) run-off tibial or fibular vessel to the foot at the end of procedure De novo or restenotic lesions, including in-stent restenosis Willingness to participate in the study and signature of informed consent Exclusion Criteria: Renal failure with glomerular filtration rate (GFR) 30 ml/min or below, estimated by the Cockroft-Gault equation. Women who are pregnant, lactating, or planning to become pregnant during the duration of the study Recent artery thrombosis, at risk of distal embolization during percutaneous procedure Previous use of a PCB in the lesion during last 15 months Extremely calcified lesions, defined by calcification involving ³ 270° of the artery circumference over ³ 15 cm. Sub-intimal recanalization Tortuous contra-lateral femoral access with difficult cross-over Previous or planned surgery of the target lesion High risk of bleeding Contra-indication to dual antiplatelet therapy for one month, and/or to single antiplatelet therapy for 1 year Allergy to aspirin, clopidogrel or heparin Life expectancy less than one year

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLEX Scoring Catheter plus DEB<br>The target lesion is prepared by the FLEX Scoring Catheter® with a 30° rotation between each passage. Angioplasty is performed during 3 minutes with paclitaxel-coated balloon(s) (PCB), all along the target lesion. | Device: FLEX Scoring Catheter<br>* Vessel preparation with the FLEX Scoring Catheter® with a 30° rotation between each passage is performed, followed by a DEB angioplasty.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of clinically driven target lesion revascularization (CDTLR) at 12 months |  | 12 months | 
| Occurrence of death from cardiovascular origin |  | 12 months | 
| Occurrence of major amputation of target limb |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency of the treated lesion (defined by PSVR ≤ 2.5 at duplex scan) |  | 3 and 12 months | 
| Absence of CDTLR |  | 3 months | 
| Absence of major amputation |  | 3 and 12 months | 
| Change in ankle brachial index (ABI) |  | 3 and 12 months | 
| Change in Rutherford class of symptom |  | 3 and 12 Months | 
| Technical success of the scoring procedure |  | Average of 2 hours | 
| Proportion of luminal gain |  | Average of 2 hours | 
| Occurrence of dissection |  | Average of 2 hours | 
| Proportion of stent implantation |  | Average of 2 hours |