NCT06321575 The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)
| NCT ID | NCT06321575 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nipro Vascular Innovations Americas, Inc |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 159 participants |
| Start Date | 2024-06-20 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 159 participants in total. It began in 2024-06-20 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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. 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 \<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 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)
Contact & Investigator
Matthew Finn, MD
PRINCIPAL INVESTIGATOR
Cardiovascular Institute of the South
Frequently Asked Questions
Who can join the NCT06321575 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06321575 currently recruiting?
Yes, NCT06321575 is actively recruiting participants. Contact the research team at Gene.Reu@nipromed.com for enrollment information.
Where is the NCT06321575 trial being conducted?
This trial is being conducted at Scottsdale, United States, Scottsdale, United States, Merced, United States, Fort Lauderdale, United States and 11 additional locations.
Who is sponsoring the NCT06321575 clinical trial?
NCT06321575 is sponsored by Nipro Vascular Innovations Americas, Inc. The principal investigator is Matthew Finn, MD at Cardiovascular Institute of the South. The trial plans to enroll 159 participants.