Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism (The ARTIST Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Change of RV/LV
研究概览
简要总结
The registry is to evaluate the safety and feasibility of catheter-directed aspiration for patients with high-risk and intermediate-high-risk pulmonary embolism using Acostream.
详细描述
The registry is a prospective, multicenter, observational study involving 130 patients across up to seven sites in China. The aim of this study is to evaluate the safety and feasibility of catheter-directed thrombectomy using Acostream in patients with high-risk and intermediate-high-risk pulmonary embolism. The primary endpoint of the study is the efficacy and safety of pulmonary thrombus removal, assessed by reduction of ventricular strain, decrease in vascular obstruction, overall clinical improvement, and the early mortality rate from pulmonary embolism. Secondary endpoints include the total mortality rate of PE and the incidence of complications in the 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18≤Age≤85
- •Clinical symptoms and presentation consistent with pulmonary embolism (PE).
- •PE symptoms duration ≤ 14 days.
- •High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy.
- •Intermediate-high risk PE patients with right ventricle dysfunction (right ventricle/ left ventricle >0.9) confirmed by computed tomography pulmonary angiography or transthoracic echocardiography.
排除标准
- •Pregnancy.
- •Refusal to sign the informed consent form.
- •Presence of intracardiac thrombus.
- •Presence of chronic left heart failure with an ejection fraction lower than 30% Diagnosed thrombophilia.
- •History of severe or chronic pulmonary hypertension.
- •Serum creatinine level higher than 1.8 mg/dl.
- •Known serious and uncontrolled sensitivity to radiographic agents.
研究组 & 干预措施
The Acostream aspiration group
The pulmonary thrombus removal by Acostream.
干预措施: Acostream aspiration (Device)
结局指标
主要结局
Change of RV/LV
时间窗: 48 hours
The ratio of right ventricular diameter to left ventricular diameter (RV/LV) decreased compared to baseline
次要结局
- Surgical success rate(Immediately after surgery)
- Changes in pulmonary artery pressure before and after surgery(48 hours)
- Changes in arterial oxygen pressure before and after surgery(14 days)
- Clinical deterioration incidence(48 hours)
- All-cause mortality rate(1, 3, 6, 12 months)
- Symptomatic PE recurrence rate(1, 3, 6, 12 months)