LEVANT 2 Safety Registry

Inclusion Criteria:

• Male or non-pregnant female ≥ 18 years of age
• Rutherford Clinical Category 2-4
• Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen
• Length ≤ 15 cm
• Up to two focal lesions or segments within the designated 15 cm length
• ≥ 70% stenosis by visual estimate
• de novo lesion(s) or non-stented restenotic lesion(s) > 90 days from prior angioplasty procedure
• Target vessel diameter between ≥ 4 and ≤ 6 mm
• Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion
• No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment

Exclusion Criteria:

• Pregnant or planning on becoming pregnant or men intending to father children; Life expectancy of < 5 years
• Patient is currently participating in an investigational drug or other device study or previously enrolled in this study
• History of hemorrhagic stroke within 3 months
• Renal failure or chronic kidney disease
• Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication
• Anticipated use of IIb/IIIa inhibitor prior to randomization
• Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel
• Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.)