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 15 investigational sites in the U.S.

The investigation is a prospective, multicenter, non-randomized, single-arm, open-label pivotal clinical study. Subjects will undergo atherectomy treatment with the Golazo® Peripheral Atherectomy System and will then be followed 6-months post-procedure.

Eligibility Criteria:
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. 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

   Angiographic inclusion criteria:
9. Target lesion(s) defined as stenosis ≥70% by angiographic visual estimation
10. Total treated lesion length ≤15 cm by angiographic visual estimation
11. Target reference vessel diameter ≥2.0 mm and ≤4.5 mm by angiographic visual estimation
12. Target lesion will have the potential of at least one patent tibial vessel runoff to the foot that crosses the ankle and provides perfusion 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 \<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

    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 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)