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

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.

General inclusion criteria:

• Age ≥18 years
• Candidate for atherectomy of the peripheral vasculature in the lower limbs
• Life expectancy >1 year in the opinion of the investigator
• 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.
• Target limb Rutherford clinical classification category 3 to 5
• Suitable candidate for angiography and endovascular intervention in the opinion of the investigator
• Willing and able to comply with the protocol-specified procedures and assessments
• Informed consent granted

Angiographic inclusion criteria:

• Target lesion(s) defined as stenosis ≥70% by angiographic visual estimation
• Total treated lesion length ≤20 cm by angiographic visual estimation
• Target reference vessel diameter (RVD) ≥2.0 mm and ≤4.5 mm by angiographic visual estimation
• 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:

• Active infection in the target limb
• History of an endovascular procedure or open vascular surgery on the target limb within the last 30 days
• Planned surgical or interventional procedure within 30 days after the index procedure
• Lesion in the contralateral limb requiring intervention during the index procedure or within next 30 days
• Critical limb ischemia (CLI) with Rutherford clinical classification category 6
• Significant acute or chronic kidney disease with a GFR <30 and/or requiring dialysis
• Acute myocardial infarction (non-ST-elevation myocardial infarction or ST-segment elevation myocardial infarction) or other uncontrolled comorbidity in the opinion of the investigator
• Myocardial infarction (MI) or stroke within two months of baseline evaluation
• Pregnant or lactating
• 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)
• Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy
• Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count <125,000/microliter, known coagulopathy, or international normalized ratio (INR) >1.5
• Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately medicated
• History of heparin-induced thrombocytopenia (HIT)
• Any thrombolytic therapy within two weeks of enrollment
• Target lesion(s) within a native vessel graft or synthetic graft
• Significant stenosis or occlusion of inflow not successfully treated before the index procedure
• Any evidence or history of intracranial or gastrointestinal bleeding or intracranial aneurysm
• Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
• One or more of the following complications of the foot:

• Osteomyelitis that extends to the metatarsal bones.
• Gangrene involving the plantar skin of the forefoot, midfoot or heel
• Deep ulcer or large shallow ulcer (>3cm) involving the plantar skin of the forefoot, midfoot, or heel
• Any heel ulcer with/without calcaneal involvement
• Any wound with calcaneal bone involvement
• Wounds that are deemed to be neuropathic or non-ischemic in nature
• Wounds that require flap coverage or complete wound management for large soft tissue defect
• Congestive heart failure with a NYHA functional classification of III or higher

Angiographic exclusion criteria:

• More than 2 lesions to be treated with the investigational device; lesions located within 3 mm may be considered a single tandem lesion
• Clinical/angiographic complication (other than non-flow limiting dissections) attributed to a currently marketed device prior to introduction of the investigational device
• In-stent restenosis within the target lesion(s)
• Potentially unstable or flow-limiting dissection, type C or greater
• Clinical/angiographic evidence of distal embolization
• Inability to cross the proximal lesion vessel lumen with a guidewire (not subintimal)