The Artix All-in-one Solution for Complete thrombEctomy With eNDovascular Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 20
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
This study is a post-market, prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.
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
- •Acute symptom duration ≤ 14 days
- •Lower limb arterial occlusion below inguinal ligament
- •Target lesion in native vessel
- •Target vessel size between 3 mm and 8 mm by visual estimation
- •Rutherford category I, IIa, or IIb
- •Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements
排除标准
- •Life expectancy < 6 months
- •Prior major amputation in the target limb
- •Prior minor amputation in the target limb that is not completely healed or cannot bear weight
- •Non-thrombotic occlusion secondary to dissection, vasculitis, or target vessel trauma
- •Treatment of the index event in the target vessel with any other endovascular thrombectomy/aspiration or open surgical method prior to Artix procedure
- •Part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions
- •Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
- •Unable to tolerate antiplatelet therapy
- •Inability to anticoagulate the patient with heparin, enoxaparin or other parenteral antithrombin, or known to have uncorrected bleeding disorders (e.g., gastro-intestinal ulcer, menorrhagia, liver failure, heparin-induced thrombocytopenia (HIT))
- •Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject (e.g., contraindication to use of Artix per local approved labeling, compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments)
- •Current participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this study
研究组 & 干预措施
Artix Thrombectomy System
Non-surgical removal of lower extremity arterial emboli and thrombi using the Artix Thrombectomy System.
干预措施: Artix Thrombectomy System (Device)
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: Immediately Following Index Procedure
Revascularization rate post-index procedure of target treatment area determined by an independent core lab.
Primary Effectiveness Endpoint
时间窗: Immediately Following Index Procedure
Revascularization rate post-index procedure of target treatment area determined by an independent core lab.
Primary Safety Endpoint
时间窗: 48 Hours
Periprocedural (within 48 hours) Artix Thrombectomy System-related major bleeding rate adjudicated as causal to the study device as determined by an independent Medical Monitor.
次要结局
- All-cause mortality(1-month follow-up visit)
- Limb salvage(1-month follow-up visit)
- Distal embolization SAEs(Intra-procedure)
- All-cause mortality(1-month follow-up visit)
- Limb salvage(1-month follow-up visit)
- Amputation-free survival(1-month follow-up visit)