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

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 withnon-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 ofthe 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 visualestimation

12. Target limb will have a minimum of one patent (less than 50% stenosis) below theknee (BTK) vessel crossing the ankle, distal to any target lesion, providingperfusion 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 limbwithin the last 30 days

3. Planned surgical or interventional procedure within 30 days after the indexprocedure

4. Lesion in the contralateral limb requiring intervention during the index procedureor 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-segmentelevation myocardial infarction) or other uncontrolled comorbidity in the opinion ofthe 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, orprocedure that has not completed the study treatment or that clinically interfereswith the endpoints of this study (post-approval registries are allowed as long asthe 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 withplatelet count <125,000/microliter, known coagulopathy, or international normalizedratio (INR) >1.5

13. Known allergy to contrast agents or medications used to perform endovascularintervention 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 theindex procedure

18. Any evidence or history of intracranial or gastrointestinal bleeding or intracranialaneurysm

19. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)

20. One or more of the following complications of the foot:

21. Osteomyelitis that extends to the metatarsal bones.

22. Gangrene involving the plantar skin of the forefoot, midfoot or heel

23. Deep ulcer or large shallow ulcer (>3cm) involving the plantar skin of theforefoot, midfoot, or heel

24. Any heel ulcer with/without calcaneal involvement

25. Any wound with calcaneal bone involvement

26. Wounds that are deemed to be neuropathic or non-ischemic in nature

27. Wounds that require flap coverage or complete wound management for large softtissue defect

28. Congestive heart failure with a NYHA functional classification of III or higher Angiographic exclusion criteria:

29. More than 2 lesions to be treated with the investigational device; lesions locatedwithin 3 mm may be considered a single tandem lesion

30. Clinical/angiographic complication (other than non-flow limiting dissections)attributed to a currently marketed device prior to introduction of theinvestigational device

31. In-stent restenosis within the target lesion(s)

32. Potentially unstable or flow-limiting dissection, type C or greater

33. Clinical/angiographic evidence of distal embolization

34. Inability to cross the proximal lesion vessel lumen with a guidewire (notsubintimal)