Company decision to halt study

To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs

Inclusion Criteria:

• Ischemic rest pain for more than 2 weeks or ulceration or gangrene of the foot or toes (Rutherford Becker Category 4, 5 or 6)
• Willing and able, as evaluated by the PI, to provide Informed Consent
• Willing to undergo up to 5 years of clinical follow up visits as scheduled
• Angiographic pattern of infrainguinal disease that can be reasonably managed either by surgery or plaque excision in the first instance
• Reconstitution of at least one patent target tibial segment below the knee which provides run-off to the foot
• The patient must be >18 years of age
• Target lesion(s) is located at or below the level of the superficial femoral artery
• Target lesion(s) is >50% stenosed by quantitative vascular angiography
• Ability to take at least one of the following types of medications: anti- platelet or anti-thrombotic therapy

Exclusion Criteria:

• Patient has cardiac or cardiovascular comorbidities that would make surgery inappropriate
• Patient has terminal or Stage 4 cancer
• Patient has extensive gangrene that requires both a Below-the-Knee amputation and a revascularization procedure
• Previous stent in the target lesion
• Active infection at planned incision site
• The patient is a pregnant woman
• The patient has significant suprainguinal or Common Femoral disease that can not be treated either prior to or during the index procedure
• Target Lesion is a Chronic Total Occlusion (CTO) that is greater than 15cm in length and has severe, continuous calcification