NCT05992168终止不适用
A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Thrombectomy Devices for the Treatment of Acute Pulmonary Embolism
Suzhou Zenith Vascular Scitech Co., Ltd.2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2024年1月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Reduction in RV/LV ratio from baseline to 48 hours
研究概览
简要总结
To evaluate treatment outcomes of patients diagnosed with pulmonary embolism.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 1.18≤ age ≤75, no gender limitation; 2.patients clinically diagnosed as acute pulmonary embolism requiring pulmonary artery thrombosis clearance; 3.RV/LV ratio ≥0.9; 4.Patients who agreed to participate in the study and voluntarily signed the informed consent.
排除标准
- •Patients with systolic blood pressure<90 mmHg and lasting for 15 minutes or requiring maintenance of systolic blood pressure ≥ 90 mmHg;
- •Patients with known severe pulmonary hypertension;
- •Patients with Hematocrit <28%;
- •Patients with known structural heart disease;
- •Patients with left bundle branch block;
- •Patients with history of chronic left heart failure and left ventricular ejection fraction ≤30%;
- •Patients with abnormal renal function (serum creatinine > 1.8 mg/dL or >159 umol/L);
- •Patients with known coagulopathy or bleeding tendency (platelet <100×109/L, or INR> 3);
- •Patients who cannot receive antiplatelet or anticoagulant therapy;
- •Patients who underwent cardiovascular or pulmonary open surgery within 7 days before peocedure;
- •Patients with intracardiac thrombosis;
- •Patients treated with extracorporeal membrane oxygenation;
- •Patients known to be allergic to contrast agents;
- •Patients with diseases that may cause difficulty in treatment or evaluation (such as malignant tumor, acute infectious disease, sepsis, general condition that cannot tolerate procedure, life expectancy less than one year, etc.);
- •Females who are pregnant or in lactation;
- •Patient is currently enrolled in another investigational study protocol;
- •Other conditions not suitable for inclusion judged by the researcher.
结局指标
主要结局
Reduction in RV/LV ratio from baseline to 48 hours
时间窗: 48 hours post procedure
Endpoint events will be assessed from the time of treatment of the pulmonary embolism through hospital discharge, or through 48 hours post treatment, whichever comes first.
Major Adverse Events from baseline to 48 hours
时间窗: 48 hours post procedure
Endpoint events will be assessed from the time of treatment of the pulmonary embolism through hospital discharge, or through 48 hours post treatment, whichever comes first.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Prevalence and Characteristics of Pulmonary Embolism on COVID-19 Patients Presenting Respiratory SymptomsCovid-19Pulmonary EmbolismNCT04420312Fondation Hôpital Saint-Joseph1,024
已完成
不适用
Pulmonary Embolism Short-term Clinical Outcomes RegistryPulmonary EmbolismNCT02883491Wake Forest University Health Sciences815
招募中
不适用
Clinical Outcomes After Acute Pulmonary EmbolismPulmonary EmbolismNCT04355975Insel Gruppe AG, University Hospital Bern800
尚未招募
不适用
A Study to Observe the Safety, Tolerability, and Efficacy of RemodulinPulmonary Arterial HypertensionNCT06603285Excelsior20
终止
不适用
Study of Diagnosis and Pathophysiology of Pulmonary Embolism (APE 1 Trial)Right Heart StrainPulmonary EmbolismNCT00302601Odense University Hospital15