Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia

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