Crosser Enters The Right Arterial Lumen (CENTRAL)

Inclusion Criteria:

• Patient must have objective evidence of lower extremity ischemia and scheduled to undergo an endovascular recanalization.
• Occluded artery must be the native superficial femoral artery.
• Patient must have a totally occlusive lesion classified angiographically as absolute (100% occlusion with no flow).
• Patient's target vessel occlusion length is ≤ 30 cm.
• Patient's reference vessel diameter is greater than or equal to 3.0mm.
• Patient must be an acceptable candidate for PTA, peripheral artery bypass surgery or peripheral artery stent implantation.
• Female patients of child bearing potential must have a negative pregnancy test within 72 hours prior to the study procedure.
• Patient or guardian must have been informed of the nature of the study, agree to its provisions, and provide written informed consent.
• Patient is ≥ 18 years of age.

Exclusion Criteria:

• Patient has hypersensitivity or contraindication to aspirin, heparin or radiographic contrast agents which cannot be adequately pre-medicated.
• The patient requires immediate treatment in more than one occluded vessel, in any combination of grafts or native vessels.
• Patient's occlusion is a flush occlusion initiating less than 2cm from the ostium.
• Patient has planned infrainguinal intervention scheduled within 30 days after index procedure.
• The patient is currently participating in another investigational drug or device trial that may conflict with study data collection and has not completed the entire follow-up period.
• Patient has no collateral flow distal to the occlusion.
• Patient's target occlusion has a dissection that occurred within the past 60 days caused by a guidewire attempt.
• Patient has a history of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency.
• Patient suffered recent (within the past 6 months) stroke or transient ischemic neurological attack (TIA).
• Patient suffered recent (within the past 6 months) significant gastrointestinal (GI) bleeding.
• Patient has other medical illnesses (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with life-expectancy less than 1 year.