The DETOUR 2 Clinical Trial

Inclusion Criteria

All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in the study:

General Inclusion Criteria

• Age > 18 and ≤ 90 years of age.
• Willing and able to provide informed consent.
• Subject is willing to undergo all follow-up assessments according to the specified schedule over 36 months.

Clinical Inclusion Criteria

• Chronic, symptomatic lower limb ischemia defined as Rutherford clinical categories 3, 4, or 5.
• Venous Clinical Severity Score 2.5mg/dL (220µmol/L) or on dialysis.
• Known hypersensitivity/allergy to the investigational devices and/or required pharmacotherapy that cannot be safely managed.
• Morbid obesity that does not allow for safe vascular access or imaging.
• Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR > 1.8.
• Requires coronary or peripheral procedure within 30 days prior to or planned within 30 days post treatment of the target lesion.
• Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 3 months.
• Subject is pregnant or breast-feeding. Angiographic Exclusion Criteria
• Stent within 3 cm of SFA ostium.
• Previous bypass surgery on the target limb.
• Subject has significant disease or obstruction (≥50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤30% residual stenosis, without complication)
• Presence of aneurysm or acute thrombus in the target limb.
• Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.