• All-cause mortality [ Time Frame: 6 and 24 months ] [ Designated as safety issue: Yes ]
• Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
• Time to onset of any of MAPE [ Time Frame: 3-24 months ] [ Designated as safety issue: Yes ]
• Binary restenosis rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Percentage diameter stenosis in duplex ultrasound [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]

The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis.

The superficial femoral artery is a common place for arteriosclerosis in patients symptomatic for lower extremity vascular disease. Advances in percutaneous transluminal angioplasty (PTA) and stenting have provided new options for the treatment of the disease in this arterial segment. Restenosis after PTA occurs in 40-60% within one year. A novel attempt to reduce restenosis is the use of paclitaxel eluting balloons (PEB). First clinical studies suggest that the use of PEBs during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. There is no randomized comparison of these treatments in patients with in stent restenosis of the superficial femoral artery. Thus, the aim of this study was to compare the efficacy of PTA with conventional balloon or PEB for in stent restenosis in the SFA in terms of reduction of diameter stenosis at follow-up angiogram.

• Device: PTA
  PTA using a conventional balloon
  Other Name: PACIFIC XTREME, Invatec
• Device: PTA with PEB
  PTA using a paclitaxel eluting balloon
  Other Name: IN.PACT PACIFIC, Invatec
• Procedure: Percutaneous Transluminal Angioplasty (PTA)
  Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon
  Other Name: PACIFIC XTREME or IN.PACT PACIFIC balloons

• Active Comparator: conventional PTA
  In stent restenosis is treated with PTA using a conventional balloon.
  Interventions:

  • Device: PTA
  • Procedure: Percutaneous Transluminal Angioplasty (PTA)
• Experimental: PTA with PEB
  In stent restenosis is treated with PTA using a paclitaxel eluting balloon.
  Interventions:

  • Device: PTA with PEB
  • Procedure: Percutaneous Transluminal Angioplasty (PTA)

Inclusion Criteria:

• Symptomatic ≥ 70% in-stent restenosis of the AFS, (Rutherford stage 2-6)
• Written, informed consent by the patient or her/his legally-authorized representative for participation in the study

Exclusion Criteria:

• Acute ischemia and/or acute thrombosis of the SFA
• Untreated ipsilateral iliac artery stenosis >70%
• Not at least one vessel run-off
• Popliteal involvement with stenosis >70%
• Severe renal insufficiency (GFR <30 ml/min/m2)
• Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
• Pregnancy (present, suspected or planned) or positive pregnancy test.
• Previous enrollment in this trial.
• Patient's inability to fully cooperate with the study protocol.