Last updated on February 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Balloon angioplasty
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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 <30 ml / min / 1.73 m) or patient with a creatinine clearance <15 ml / min
  • External compression of previously implanted stent
  • Patient participating in any clinical trial using another investigational drug or product 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 (residual lesion> 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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