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