Paclitaxel Eluting Balloon and Conventional Balloon for In-Stent Restenosis of the Superficial Femoral Artery

Launched by DEUTSCHES HERZZENTRUM MUENCHEN · Mar 8, 2010

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• 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.