SOLARIS Endoprosthesis in Iliac Occlusive Disease

Solaris Endoprosthesis Performance in Treatment of Patients With Peripheral Occlusive Arterial Disease in the Iliac Territory - Post-Marketing Solaris I Study.

Fifty patients will be treated with Solaris Endoprosthesis and followed up to 2 years with Walking Impairment Questionnaire and Doppler Ultrasound evaluation in 30 days, 6 months and 12 months.

Inclusion Criteria:

• Rutherford Class 2 to 5;
• Tasc II Class A, B, C or D;
• Unilateral or bilateral lesion, de novo or restenotic but not in-stent;
• Target lesion of 3 to 10 cm length;
• ≥ 50% stenosis or common iliac or external iliac artery;
• Reference vessel diameter ≥ 5 and ≤ 9 mm;
• Deep femoral artery patent and at least one infrapopliteal artery patent;
• Informed Consent provided.

Exclusion Criteria:

• Thrombocytopenia induced by heparina or tPA intravenous, clopidogrel, ticlopidine or aspirin sensitivity;
• Target lesion near to aneurysm, highly calcified or excessively tortuous;
• Previous stent on target vessel;
• Presence of other lesions that need treatment within 30 days;
• Rutherford Class 6;
• Acute thrombotic occlusion;
• History on amputation on the target limb.