Shockwave IVL + DES

Exclusion Criteria

• •Not treated ipsilateral significant (\>50%) stenosis of the iliac arteries
• •Non severely calcified disease (absence of calcification, PACSS 1, PACSS 2)
• •Significant (\>50%) stenosis of all infrapopliteal arteries, no patent artery to the foot
• •Angiographic evidence of thrombus within the target vessel
• •Thrombolysis within 72 hours prior to the index procedure
• •Previously stented target lesion / vessel
• •Subjects who have undergone prior surgery of the target lesion SFA/PPA to treat atherosclerotic disease
• •Bypass Anastomosis stenosis
• •Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
• •Recent MI or stroke \<30 days prior to the index procedure
• •Life expectancy less than 24 months
• •Known or suspected active infection at the time of the index procedure
• •Known or suspected major allergies or contraindications to aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or contrast agent
• •Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimalparticipation in the study
• •The subject is currently participating in another drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
• •Female subjects pregnant, breastfeeding, of childbearing potential who are planning to become pregnant in the next 5 years.
• •End-stage-renal disease
• •Presence of Severe Ischemic Ulcers or frank gangrene (Rutherford class 6).