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

Eligibility Criteria

• 1. Age ≥18 years
• 2. Candidate for atherectomy of the peripheral vasculature in the lower limbs
• 3. Life expectancy \>1 year in the opinion of the investigator
• 4. Either of the following objective hemodynamic criteria:
• 1. Resting ankle brachial index (ABI) ≤0.90, or ≤0.75 after exercise
• 2. Subjects with non-compressible arteries (ABI \>1.1) with a toe brachial index (TBI) ≤0.80
• 5. Target limb Rutherford clinical classification category 3 to 5
• 6. Suitable candidate for angiography and endovascular intervention in the opinion of the investigator
• 7. Willing and able to comply with the protocol-specified procedures and assessments
• 8. Informed consent granted
• 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