Phase
Condition
N/ATreatment
Excimer Laser
Drug-coated balloons
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient of age > 18 years
Patient with previously peripheral implanted stent(s) located in or extending to thepopliteal 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 arterialsegment in association with clinical symptoms of claudication or an critical limbischemia 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 besigned prior initiation of any study related intervention)
Exclusion
Exclusion Criteria:
Life expectancy >18 months
Patient already included in this study (recruitment of the contralateral leg is notallowed)
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 <30 ml / min / 1.73 m²) or patient with acreatinine clearance <15 ml / min
External compression of previously implanted stent
Patient participating in any clinical trial using another investigational drug orproduct which could interfere with the interpretation of the trial results.
Patient under trusteeship or guardianship
Angiographic exclusion criteria :
Inflow (above) severe lesion >70% or occlusion untreated satisfactorily (residuallesion> 50%) before the management of the target lesion
Perforation, dissection or lesions on the arterial network access requiring anassumption prior to randomization
Stent fracture grade 4 or 5 at the target lesion
Study Design
Study Description
Connect with a study center
Clinique Rhône Durance
Avignon, 84000
FranceSite Not Available
Centre Hospitalier Universitaire de Besançon
Besançon, 25030
FranceSite Not Available
University Hospital of Bordeaux - Hospital Pellegrin
Bordeaux, 33000
FranceSite Not Available
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63000
FranceSite Not Available
Centre Hospitalier Universitaire de Dijon
Dijon, 21079
FranceSite Not Available
Hospices Civils de Lyon
Lyon, 69000
FranceSite Not Available
Centre Hospitalier Universitaire de Nantes
Nantes, 44093
FranceSite Not Available
Polyclinique Les Fleurs
Ollioules, 83190
FranceSite Not Available
Hôpital Européen Georges Pompidou - AP-HP de Paris
Paris, 75015
FranceSite Not Available
Clinique de L'Europe
Rouen, 76100
FranceSite Not Available
Centre Hospitalier Universitaire de St Etienne
Saint-Etienne, 42055
FranceSite Not Available
Centre Hospitalier Universitaire de Strasbourg
Strasbourg, 67091
FranceSite Not Available
Clinique Pasteur
Toulouse, 31076
FranceSite Not Available

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