Rio Trial - ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease

Inclusion Criteria: Patients with a history of peripheral artery disease with superficial femoral or popliteal artery occlusion, which mandates PTA or stent administration as first treatment modality. The history of peripheral artery occlusion has to be at least 6 weeks, and the target vessel occlusion has to be more than 5 centimeters in length. Age between 18 and 90 years Exclusion Criteria: Acute limb ischemia Subacute ischemia with requires thrombolysis as first treatment modality Active bleeding or known bleeding diathesis Known severe hepatic or renal disorder (liver cirrhosis, stage B, C or serum creatinine > 2.5 mg%) Hyperthyreosis Diabetes mellitus treated with metformin Known heparin induced thrombocytopenia (HIT, type 2) Female sex with childbearing potential Major surgery or trauma in past 6 weeks History of stroke within the previous 2 years, or any stroke with a residual neurological deficit, or other CNS abnormality (e.g., intracranial neoplasm, arteriovenous malformation, or aneurysm) Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks Administration of oral anticoagulants within the previous 7 days unless prothrombin time is < 1.2 times control (or international normalized ratio [INR] <1.4), or ongoing treatment with oral anticoagulants History of bleeding diathesis of platelet count < 100,000/mm3 Arteriovenous malformations or aneurysms Severe uncontrolled hypertension (treated sys. BP > 200 mm Hg, diast. BP > 100 mm Hg) Hypertensive or diabetic retinopathy Vasculitis Known autoimmune disorders Patient with aspirin intolerance Contraindication or known allergic reactions to abciximab or murine proteins Co-existent condition associated with a limited life expectancy (e.g., advanced cancer, end-stage congestive heart failure) Participation in another clinical research study involving the evaluation of another investigational drug or device within 7 days prior to enrollment Patient who has previously received a GP IIb/IIIa antagonist