Pulmonary Embolism Removal With the AngioJet 6F Ultra SystEm (PERFUSE)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 12
- 主要终点
- Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography
研究概览
简要总结
The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety, efficacy, adverse events and any new information that may surface regarding the use of the AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main pulmonary and lobar arteries ≥ 6mm in diameter.
详细描述
Despite advances in prophylaxis, diagnostic modalities, and therapeutic options, pulmonary embolism remains a commonly under diagnosed and lethal entity. In the United States approximately 150,000 patients per year are diagnosed with acute pulmonary embolisms. Many additional deaths occur each year in the United States as a result of undiagnosed massive pulmonary embolisms. Taking these patients into account, it is thought that up to 600,000 patients develop a pulmonary embolism annually in this country. In patients with acute pulmonary embolism, the most common cause of early death is right ventricular failure.
In addition to anticoagulation therapy, several reperfusion therapies are being used to reverse right ventricular failure: systemic thrombolysis, surgical embolectomy, and catheter based therapy. Given the drawbacks of systemic thrombolytic therapy or surgical embolectomy, percutaneous catheter treatment is a reasonable alternative for patients with contraindications to systemic thrombolytic therapy or surgery. Current international consensus guidelines support the use of catheter interventions for selected pulmonary embolism patients at increased risk of adverse clinical outcomes.
The AngioJet Ultra PE Thrombectomy catheter introduces a pressurized high velocity saline stream through a catheter tip so that the clot within a blood vessel is trapped, broken into small pieces and aspirated from the body.
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
- •Symptomatic pulmonary embolism patients >18 years
- •Availability of a baseline contrast-enhanced chest computed tomogram or conventional pulmonary angiogram with evidence of pulmonary embolus in at least one main or lobar pulmonary artery ≥ 6mm in diameter
- •Availability of a baseline transthoracic echocardiogram with sufficient image quality permitting the measurement of right ventricular (RV) and left ventricular (LV) dimensions in the apical or subcostal four-chamber view
- •Echocardiographic evidence of right ventricular dilatation with a subannular RV/LV ratio ≥ 0.9 from the apical or subcostal four-chamber view
- •Appropriate informed consent was obtained from the patient or legal representative
排除标准
- •Patient has underwent Cardiopulmonary Resuscitation (CPR) in the last 48 hours
- •Patient is participating in any other clinical study
- •Pregnancy, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested or use a medically accepted method of birth control)
- •Inability to comply with study Follow-up assessments (e.g. due to geographic)
- •Previous enrollment in this study
研究组 & 干预措施
AngioJet Ultra PE Thrombectomy System
Patients are treated with the AngioJet Ultra PE Thrombectomy System
干预措施: AngioJet Ultra PE Thrombectomy System (Device)
结局指标
主要结局
Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography
时间窗: Baseline to 24-48 hours
The change in the subannular end-diastolic RV/LV ratio at 24-48 hrs following thrombectomy compared to baseline measurements as assessed by an independent core lab analysis. RV and LV values will be measured by echocardiography, a technique utilizing ultrasound waves to assess heart activity.
次要结局
- Technical Success(Index Procedure)
- Death - All Cause(3 months)
- Pulmonary Systolic Arterial Blood Pressure(Post Index Procedure)
- Systemic Systolic Arterial Blood Pressure(Post Index Procedure)
- Change in Heart Rate(Baseline to Post Index Procedure)
- Procedure Related Adverse Event Rate(3 months)
- Death - Cardiac Cause(3 months)
- Vasopressor Support(Index Procedure)
- Change in Systolic Pulmonary Arterial Blood Pressure(Baseline to Post Index Procedure)
- Change in Systemic Systolic Arterial Blood Pressure(Baseline to Post Index Procedure)