Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease

Inclusion Criteria

• General Inclusion
• At least 18 years of age;
• Symptomatic disease: presence of critical limb ischemia (including tissue loss or rest pain), or lifestyle-limiting claudication requiring intervention in iliac and/or superficial femoral arteries;
• The subject or the legally authorized representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.
• Angiographic Inclusion

Presence of superficial femoral artery and/or iliac stenosis (>50%) or occlusion of up to 50 mm in length as determined by angiogram prior to index interventional procedure.

Exclusion Criteria

• General Exclusion
• Failure/inability/unwillingness to provide informed consent;
• Target vessel has been previously treated with bypass;
• Has an abdominal aortic aneurysm contiguous with the iliac artery target lesion;
• Has contraindication to anticoagulation;
• Has bleeding or a hypercoagulability disorder;
• Thrombocytopenia;
• Elevated international normalized ratio (>1.5);
• Elevated serum creatinine (≥2.5 mg/dL);
• Active infection;
• Contraindication to contrast; or
• Enrolled in concurrent clinical study.
• Angiographic Exclusion
• Target vessel:
• shows evidence of previous dissection or perforation, or
• has adjacent acute thrombus;
• Lesion is highly calcified;
• Lesion requires use of any atherectomy device during the procedure;
• Has a pre-existing target artery aneurysm or perforation or dissection of the target artery prior to initiation of the interventional procedure.