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

The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial disease (PAD) in up to 20 investigational sites in the U.S.

General inclusion 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. Resting ankle brachial index (ABI) ≤0.90, or ≤0.75 after exercise. Subjects with non-compressible arteries shall have a toe brachial index (TBI) assessment. 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 Angiographic inclusion criteria: 9. Target lesion(s) defined as stenosis ≥70% by angiographic visual estimation 10. Total treated lesion length ≤20 cm by angiographic visual estimation 11. Target reference vessel diameter (RVD) ≥2.0 mm and ≤4.5 mm by angiographic visual estimation 12. Target limb will have a minimum of one patent (less than 50% stenosis) below the knee (BTK) vessel crossing the ankle, distal to any target lesion, providing perfusion to the foot at baseline General 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 \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 Angiographic exclusion criteria: 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)