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

Официальное название

The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS)
  Golazo® Peripheral AS is a sterile, single-use percutaneous device that has two main components: 1) the Golazo® Accustrike atherectomy catheter, and 2) the Golazo® motorized drive unit (MDU) and is intended for use in atherectomy of the peripheral vasculature.

Первичные конечные точки

• Freedom from major adverse events (MAE) [Срок оценки: Index procedure through 30-day follow-up]
• Technical success [Срок оценки: During surgery/procedure]

Вторичные конечные точки (11)

• Change in % stenosis in target lesion after treatment with Golazo Peripheral AS [Срок оценки: During surgery/procedure]
• Procedural Success Rate [Срок оценки: End of surgery/procedure]
• Clinical Success Rate [Срок оценки: 30-day and 6-month follow-up]
• Rates of all adverse events classified as MAEs [Срок оценки: 30-day and 6-month follow-up]
• Incidence of minor target limb amputation [Срок оценки: 30-day and 6-month follow-up]
• Incidence of myocardial infarction [Срок оценки: 30-day and 6-month follow-up]
• Incidence of target vessel revascularization (TVR) in the target limb [Срок оценки: 30-day and 6-month follow-up]
• Incidence of angiographic procedural distal embolization in the target limb [Срок оценки: During surgery/procedure]
• Time to primary patency of the target lesion(s) [Срок оценки: 6 months]
• Time to assisted primary patency of the target lesion(s) [Срок оценки: 6 months]
• Time to secondary patency of the target lesion(s) [Срок оценки: 6 months]

Критерии участия

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 20 центров

• HonorHealth Scottsdale Osborn Medical Center — Scottsdale
• Pulse Cardiovascular Institute — Scottsdale
• Merced Vascular — Merced
• Palm Vascular Center — Fort Lauderdale
• First Coast Cardiovascular Institute — Jacksonville
• Radiology and Imaging Specialists of Lakeland — Lakeland
• Amavita Research Services — Miami
• Cardiovascular Consultants of South Georgia — Thomasville
• … и ещё 12 центров

Идентификаторы

NCT: NCT06321575 · AVA-CL-5000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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