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

Launched by AVANTEC VASCULAR · Mar 14, 2024

Keywords

ClinConnect Summary

The GREAT Trial is studying the Golazo® Peripheral Atherectomy System, which is a device used to treat patients with Peripheral Arterial Disease (PAD) in their legs. The goal of the trial is to ensure that this device is safe and effective for people who have symptoms of PAD, which can cause pain and discomfort in the legs due to poor blood flow. Researchers are looking for 159 participants at different locations across the U.S. who meet certain criteria, such as being at least 18 years old, having a specific level of blood flow in their legs, and being suitable for a procedure that opens up narrowed blood vessels.

If you or a loved one is considering participating, it’s important to know that eligible participants will need to provide informed consent and may undergo various assessments throughout the study. The trial is currently recruiting participants, and involvement could help advance treatment options for individuals with PAD. However, there are some health conditions that would exclude someone from participating, such as active infections, recent surgeries, or certain severe health issues. Overall, this trial aims to find better ways to improve blood flow in patients suffering from PAD, potentially leading to better quality of life and reduced symptoms.

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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)