Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis

The aim of this multicenter triple-arm randomized study is to compare two innovative techniques with the gold standard currently used and providing unsatisfactory results for the In-Stent Restenosis (ISR) treatment in femoro-popliteal arteries. This protocol compares the use of drug-coated balloons (paclitaxel - antimitotic) used alone or in association with the Excimer Laser to recalibrate the vessel lumen into the stent by destroying the whole fibrous material to the standard angioplasty using plain balloons. INTACT study main objective is to assess cost-effectiveness ratio of the treatment of femoropopliteal artery in-stent restenosis by comparing these two innovative strategies and the standard one in terms of cost per Qaly (Quality adjusted life-years) gained at 18 months from a collective perspective.

Inclusion Criteria: * Patient of age \> 18 years * Patient with previously peripheral implanted stent(s) located in or extending to the popliteal artery * Patient who received this stent between 3-36 months before inclusion * Patient with one or more in-stent restenosis lesion(s) \> 70% in the same arterial segment in association with clinical symptoms of claudication or an critical limb ischemia with Rutherford classification of 2, 3, 4 or 5 * Reference vessel diameter between 4 and 7 mm * Patient affiliated to a social security regimen * EC-approved consent form signed by the participant and the investigator (must be signed prior initiation of any study related intervention) Exclusion Criteria: * Life expectancy \>18 months * Patient already included in this study (recruitment of the contralateral leg is not allowed) * Patient contraindicated for the use of antiplatelet therapy * Pregnant or breast-feeding women * Patient with a target limb infection being treated * Patient with a procoagulant blood disease * Patient with history of contrast agents allergies * Patient with intolerance to paclitaxel * Patient with severe renal impairment (GFR \ 50%) before the management of the target lesion * Perforation, dissection or lesions on the arterial network access requiring an assumption prior to randomization * Stent fracture grade 4 or 5 at the target lesion