Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia (PROOF)

This is an interventional treatment trial for Peripheral Vascular Diseases focused on measuring CLI, Critical Limb Ischemia, PAD, Peripheral Arterial Disease, Artherosclerosis, Leg Pain, Cardiovascular, Artherectomy, Bypass, Peripheral Bypass, PROOF Read More

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