NCT06321575招募中不适用
The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy
Nipro Vascular Innovations Americas, Inc36 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2024年6月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 159
- 试验地点
- 36
- 主要终点
- Freedom from major adverse events (MAE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Golazo® Peripheral Atherectomy System
Experimental
Treatment atherectomy of the peripheral vasculature with the Golazo® Peripheral Atherectomy System.
干预措施: Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS) (Device)
结局指标
主要结局
Freedom from major adverse events (MAE)
时间窗: Index procedure through 30-day follow-up
MAE is defined as: * Clinically-driven target lesion revascularization (CD-TLR) * Cardiovascular-related deaths * Unplanned major target limb amputation (above the ankle) * Perforations or dissections grade C or greater in the target vessel that require intervention * Symptomatic distal emboli requiring intervention * Pseudoaneurysm requiring intervention
Technical success
时间窗: During surgery/procedure
Defined as the percent of target lesions that have a residual diameter stenosis ≤50% after atherectomy with the Golazo Peripheral AS and prior to adjunctive therapy
次要结局
- Incidence of myocardial infarction(30-day and 6-month follow-up)
- Time to primary patency of the target lesion(s)(6 months)
- Time to assisted primary patency of the target lesion(s)(6 months)
- Change in % stenosis in target lesion after treatment with Golazo Peripheral AS(During surgery/procedure)
- Procedural Success Rate(End of surgery/procedure)
- Clinical Success Rate(30-day and 6-month follow-up)
- Incidence of angiographic procedural distal embolization in the target limb(During surgery/procedure)
- Rates of all adverse events classified as MAEs(30-day and 6-month follow-up)
- Incidence of minor target limb amputation(30-day and 6-month follow-up)
- Incidence of target vessel revascularization (TVR) in the target limb(30-day and 6-month follow-up)
- Time to secondary patency of the target lesion(s)(6 months)
研究者
研究点 (36)
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