NCT05873452已完成不适用
Kaitoh Atherectomy System: Peripheral Artery Revascularization of Stenotic/Restenotic Disease Using the Atherectomy System in the Peripheral Arteries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Freedom from major adverse events (MAEs)
研究概览
简要总结
This is a prospective, multi-center and single-arm clinical study to assess the initial safety and effectiveness of the Kaitoh Atherectomy System for the treatment of de novo and/or restenotic lesion(s) in the peripheral arteries.
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
- •Age ≥18 years old
- •Rutherford Classification: 3-5 in target limb; Rutherford Classification 3 subjects may be enrolled but will be capped to a limit of 20% of the total enrollment (no more than two Rutherford Class 3 subjects may be enrolled into the study).
- •Able and willing to provide informed consent, and comply with follow-up visits at both 30 days and 180 days (6 months)
- •Able to comply with antiplatelet therapy as required
- •Reference Vessel Diameter is ≥2.0 mm and ≤4.0 mm
- •Target lesion length is ≤150 mm
- •De novo or restenotic target lesion(s) (except for in-stent restenotic lesion) with stenosis ≥70%, by visual estimation, in a single limb in a single native vessel
- •Inflow artery is patent, free from significant lesion stenosis (≥50% stenosis is considered significant) as visually confirmed by angiography. Note: Successful inflow artery treatment is allowed during the index procedure. Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤50% without major vascular complications (absence of flow limiting dissection, embolic event)
- •Guidewire has successfully crossed the target lesion(s) within the true lumen
排除标准
- •Females who are pregnant or lactating
- •Pre-existing illness with life expectancy <1 year
- •Known or suspected systemic infection
- •Significant gastrointestinal bleeding or any coagulopathy that would preclude the use of anti-platelet therapy
- •Subjects with a diagnosis of osteomyelitis and are currently on IV antibiotic therapy
- •Endovascular or surgical procedure performed on the target lesion within 3 months of the index procedure
- •Subjects who in the opinion of the Investigator have underlying kidney disease and may be at risk for contrast-induced acute kidney injury (AKI)
- •Subjects who in the opinion of the Investigator have uncontrolled diabetes
- •Allergic to iodine/radiopaque contrast that in the opinion of the Investigator cannot be adequately pre-treated
- •History of Coronary Artery Bypass Graft (CABG), unstable angina pectoris, or myocardial infarction within 30 days and/or hemorrhagic stroke within 90 days
- •Subjects scheduled to undergo a planned major amputation of the lower limb above the ankle on the target limb
- •Allergic to any of the components of the atherectomy device system
- •Intraprocedural complications prior to use of the investigational device
- •Subjects with a positive COVID-19 test within the last 60 days and/or is symptomatic, at the Investigator's discretion
- •Subject with other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre - and post-treatment
- •Presence of flow-limiting stenosis (>50% diameter reduction) or occlusion of inflow vessels that was not successfully treated (<50% residual stenosis without flow limiting dissection) before the study intervention/prior to the point of enrollment
- •No obvious angiographic evidence of flow to the foot following inflow treatment
- •Co-existing aneurysmal disease requiring treatment
- •Presence of vessel dissection at the target lesion requiring stent placement
- •Clinical/angiographic evidence of distal embolization or acute thrombus
- •Severe calcification that is measured >10mm in length and circumferential
- •Prior stent placement in the target lesion
结局指标
主要结局
Freedom from major adverse events (MAEs)
时间窗: 30 days post-procedure
Primary Safety
Technical success as confirmed by angiography core lab
时间窗: through completion of interventional 1 day procedure
Effectiveness
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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