NCT06747117招募中不适用
STRIDE II: A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System II
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 59
- 主要终点
- Target Limb Salvage Rate
研究概览
简要总结
The primary objective of this study is to collect and evaluate clinical evidence supporting the safety and performance of the Indigo™ Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with a confirmed diagnosis of lower limb arterial occlusion located in the common iliac or below, with a minimum of 2 cm of proximal patency in the common iliac
- •Acute occlusion with symptom duration of 14 days or less at presentation
- •ALI Rutherford Category I, IIa or IIb
- •First-line treatment with the Indigo Aspiration System using Computer Assisted Vacuum Thrombectomy (CAVT) aspiration tubing
- •Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements
- •Previously enrolled patients presenting with a new acute occlusion in the contralateral limb meeting all eligibility criteria may be re-enrolled if the new acute occlusion is greater than 30 days from the initial index procedure
排除标准
- •Life expectancy <1 year
- •Target vessel size <2 mm
- •Target thrombus is in the aorta or isolated profunda artery
- •Prior major amputation (proximal to the tarsometatarsal joint) in the target limb
- •Prior minor amputation in the target limb within the past 6 months that is not completely healed or cannot bear weight
- •LE ALI secondary to dissection, vasculitis, or target vessel trauma, including iatrogenic etiology from treatment of a proximal location in the target limb, and non-thrombotic material such as tumor fragments, fat emboli, septic emboli, and foreign bodies
- •Target thrombus in a vein bypass graft, previously revised bypass grafts, bypass grafts placed < 3 months prior to index ALI symptom onset, or bypass grafts with a distal anastomosis below the popliteal artery
- •Treatment of the index event with thrombolytics or any other endovascular or open surgical method prior to enrollment
- •Pregnancy
- •Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
- •Other medical, behavioral, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
- •Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become
研究组 & 干预措施
Patients with lower extremity acute limb ischemia
Device: Indigo Aspiration System
干预措施: Indigo Aspiration System (Device)
结局指标
主要结局
Target Limb Salvage Rate
时间窗: 30 Days Post-Procedure
次要结局
- Primary Patency at 30 Days(30 Days Post-Procedure)
- Rates of Device-related Major Bleeding(Procedure, 30 Days, and 180 Days Post-Procedure)
- Rates of Device-related Distal Embolization(During Procedure)
- Rates of Device-related Serious Adverse Events (SAE)(Procedure, 30 Days, and 180 Days Post-Procedure)
- Mortality(30 Days and 180 Days Post-Procedure)
- Technical Success(Immediate Post Procedure)
研究者
研究点 (59)
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