Evaluation of the Clinical Outcomes of the Embolic Protection System in Preventing Distal Embolism During Femoropopliteal Debulking Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 30-day freedom from Major adverse events (MAEs)
研究概览
简要总结
Patients with femoropopliteal arterial lesions requiring debulking procedures. The objective of this study is Evaluation of the clinical outcomes of the Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures (The EPISODE study).
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
- •Rutherford classification 2-5
- •Patients with chronic femoropopliteal obstruction or thromboembolism who require debulking prior to other endovascular treatments.
- •Patients who understand the purpose of this study, participate in the study voluntarily, sign the informed consent and are willing to receive follow-up visits
- •The guidewire needs to pass through the lesion
- •Life expectancy >24 months
- •Moderate to severe calcified lesions confirmed by imaging
- •For patients who receive intervention in both lower extremities, they may be enrolled in order of time of endovascular therapy
- •For combined aortoiliac artery lesions, recanalization of blood flow through endoluminal reconstruction of the vessel without more than 50% residual stenosis.
排除标准
- •Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or cardiac infarction within 3 months prior to enrollment
- •Patients with known allergy to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
- •Patients who have been treated with drugs that interfere with this clinical trial or intraoperatively with other special vascular bed preparation devices, such as plaque volume reduction devices, special balloons, etc., within the last 3 months;
- •Pregnant and lactating women
- •Patients who are unable or unwilling to participate in this trial
- •patients with Berger's disease
- •Patients who have undergone arterial bypass on the treated side
结局指标
主要结局
30-day freedom from Major adverse events (MAEs)
时间窗: 30 days after intervention
Incidence of no major adverse events within 30 days. Major adverse event is defined as death; acute cardiac infarction; unplanned amputation; acute thrombosis of the target vessel; serious complications related to the filter, such as vessel perforation, detachment of the filter, and severe entrapment (type D,E,F); distal embolism with clear clinical signs (specifically, the presence of imaging evidence of clear distal embolism at the distal end of the filter, with severe manifestations of ischemia that require further endoluminal or surgical intervention for relief, or cause tissue damage/longer hospitalization).
次要结局
- Device Success Rate(Immediately after intervention)
- Technical success rate(Immediately after intervention)