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

Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.