The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)

Exclusion Criteria

• •1. Active infection in the target limb
• •2. History of an endovascular procedure or open vascular surgery on the target limb within the last 30 days
• •3. Planned surgical or interventional procedure within 30 days after the index procedure
• •4. Lesion in the contralateral limb requiring intervention during the index procedure or within next 30 days
• •5. Critical limb ischemia (CLI) with Rutherford clinical classification category 6
• •6. Significant acute or chronic kidney disease with a GFR \<30 and/or requiring dialysis
• •7. Acute myocardial infarction (non-ST-elevation myocardial infarction or ST-segment elevation myocardial infarction) or other uncontrolled comorbidity in the opinion of the investigator
• •8. Myocardial infarction (MI) or stroke within two months of baseline evaluation
• •9. Pregnant or lactating
• •10. Subject is participating in another clinical investigation of a device, drug, or procedure that has not completed the study treatment or that clinically interferes with the endpoints of this study (post-approval registries are allowed as long as the investigator determines there is no clinical interference with study endpoints)
• •11. Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy
• •12. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count \<125,000/microliter, known coagulopathy, or international normalized ratio (INR) \>1.5
• •13. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately medicated
• •14. History of heparin-induced thrombocytopenia (HIT)
• •15. Any thrombolytic therapy within two weeks of enrollment
• •16. Target lesion(s) within a native vessel graft or synthetic graft
• •17. Significant stenosis or occlusion of inflow not successfully treated before the index procedure
• •18. Any evidence or history of intracranial or gastrointestinal bleeding or intracranial aneurysm
• •19. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
• •20. One or more of the following complications of the foot:
• •1. Osteomyelitis that extends to the metatarsal bones.
• •2. Gangrene involving the plantar skin of the forefoot, midfoot or heel
• •3. Deep ulcer or large shallow ulcer (\>3cm) involving the plantar skin of the forefoot, midfoot, or heel
• •4. Any heel ulcer with/without calcaneal involvement
• •5. Any wound with calcaneal bone involvement
• •6. Wounds that are deemed to be neuropathic or non-ischemic in nature
• •7. Wounds that require flap coverage or complete wound management for large soft tissue defect
• •21. Congestive heart failure with a NYHA functional classification of III or higher
• •22. More than 2 lesions to be treated with the investigational device; lesions located within 3 mm may be considered a single tandem lesion
• •23. Clinical/angiographic complication (other than non-flow limiting dissections) attributed to a currently marketed device prior to introduction of the investigational device
• •24. In-stent restenosis within the target lesion(s)
• •25. Potentially unstable or flow-limiting dissection, type C or greater
• •26. Clinical/angiographic evidence of distal embolization
• •27. Inability to cross the proximal lesion vessel lumen with a guidewire (not subintimal)