Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries

Exclusion Criteria

• •1. Patients with more than two lesions in the target vessel requiring treatment (if the distance between two lesions is less than 2 cm, the lesions should be counted as one lesion). The second lesion should also be treated with either coated or uncoated balloons (according to the randomization)
• •2. Guidewire cannot cross lesion and/or an intentional subintimal approach in the stented lesion is required.
• •3. Patients with stent fractures grade 2-4.
• •4. Inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to treatment of the study lesion.
• •5. Acute thrombosis of the study lesion requiring lysis or thrombectomy prior to the treatment of the study lesion.
• •6. Acutely occurring symptoms with a lyses or an operation as a therapeutic option within the last 6 weeks within the study limb.
• •7. Potential loss of leg due to critical or acute ischemia.
• •8. No patent distal run-off vessel.
• •9. Aneurysm in the blood vessel intended for intervention in this study.
• •10. Blood platelet count \< 100.000/mm3 or \>700.000/mm3, leukocyte count \< 3.000/mm3.
• •11. Contra-indication to anticoagulation, or any anti-platelet agent (e.g. aspirin, heparin, clopidogrel, ticlopidine, abciximab), or paclitaxel.
• •12. Known intolerance or contra-indication (e.g. severe hepatic (with ALAT and/or ASAT \> 3 times the normal reference range) or renal (creatinine \> 1.1 mg/dl in women and \>1.5 mg/dl in men) to contrast agents which cannot be adequately pre-treated, e.g. with adequate hydration.
• •13. Severe illnesses such as cancer, liver or renal diseases, myocardial insufficiency leading to protocol deviations and/or a reduced life expectancy of less than 2 years.
• •14. Manifest hyperthyreosis.
• •15. Latent hyperthyreosis without adequate therapy, e.g., previous blocking with Natriumperchlorat (Irenat®).
• •16. Significant gastrointestinal hemorrhage within the previous 6 months prior to study participation.
• •17. History of hemorrhagic diathesis or coagulopathy or rejection of blood transfusions.
• •18. Medical reason against double anti-platelet therapy in anti-coagulated patient, e.g., receiving coumadine.
• •19. Any severe medical condition that might interfere with the interpretation of the data or result in an unacceptable risk for the patient's participation in the study, according to the judgment of the clinical investigator.
• •20. Female patient who is pregnant or lactating.
• •21. Patient under 18 years of age.
• •22. Participation in another clinical study up to 30 days prior to study entry.
• •23. Previous participation in the same trialstudy (only one leg can be treated within the study).