Prospective Observational Study to Evaluate the Use of Computer-Aided Vacuum Thrombectomy Within the Context of Intermediate and High-Risk Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- LV/RV ratio
研究概览
简要总结
Pulmonary embolism is a blood clot on the lung, which can cause death or significant reduced quality of life. Sucking the clot out with a special tube (catheter) is a relatively new procedure that can be performed but doesn't have the data required to properly support its use in some patients. We know this procedure works in patients who have no other options and would almost certainly die without intervention. We currently don't know how well this procedure is tolerated, how well it works and what its complications are in patients who are moderately to severely unwell. The National Institute of Clinical Excellence (NICE), an advisory body, suggests more data is required to support its use in patients who are sick or very sick. This registry aims to support this growing evidence base to workout if the treatment is effective and the associated risks that come with using it. We are collecting data about this procedure and other treatments patients get offered to better inform clinicians and researchers.
详细描述
Acute intermediate-risk pulmonary embolism (PE) and high-risk PE can be life threatening. The incidence of PE is increasing , and patients who survive the acute presentation may experience significant morbidity including reduced exercise tolerance, and decreased quality of life (QoL). Often patients are treated with anticoagulation to stop the clot getting worse and encourage the body to slowly break up the clot. However in more severe cases thrombolysis medication can be given to actively break up the clot. Catheter directed thrombolysis can be used to target the lytic medication into the pulmonary arteries and reduced the systemic effects. Percutaneous thrombectomy is a newer treatment option that aspirates the clot, providing a faster and potentially lytic free solution to sick patients. Pulmonary artery thrombectomy (PAT) is a treatment option that is variably utilised and has unclear evidence base . The penumbra device uses a computer modulated vacuum aspiration system to both fatigue, breakup and aspirate the clot. This has been shown to be safe and effective in small cohorts. CAVT can prevent acute hemodynamic decompensation, alleviate acute PE-related symptoms, accelerate right ventricular recovery, and improve quality of life as measured by patient-reported outcomes (PROs). Despite existing literature addressing clinical outcomes with PE treatment, comprehensive data on PE-related morbidity, PROs and longer-term outcomes after mechanical thrombectomy are still lacking.
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
- •Clinical signs and symptoms consistent with acute pulmonary embolism with duration of 14 days or less
- •Patients who present with computed tomography confirmed pulmonary embolism
- •Defined as intermediate or high-risk pulmonary embolism (according to European Society of Cardiology guidelines)
- •Date of computed tomography imaging from within a two-year period
- •Patient is greater than or equal to 18 years of age
- •Informed consent obtained
- •Evidence of cardiac dysfunction (either biochemical or imaging features of right heart strain)
排除标准
- •Known serious, uncontrolled sensitivity to radiographic agents
- •Computed tomography not available to evaluate pulmonary embolism
- •Low-risk pulmonary embolism as defined by European Society of Cardiology guidelines
- •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 commercially available are not considered investigational
- •Other medical, social, or psychological conditions that, in the opinion of the investigator, preclude 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
- •Inclusion Criteria:
- •Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
- •Patients who present with CT confirmed PE
- •Defined as intermediate or high-risk PE (according to ESC guidelines1)
- •Date of CT imaging from within a two-year period
- •Patient is ≥ 18 years of age
- •Informed consent obtained
- •Evidence of cardiac dysfunction (Either biochemical or imaging features of RHS)
- •Exclusion Criteria:
- •1. Known serious, uncontrolled sensitivity to radiographic agents
- •CT not available to evaluate PE
- •Low Risk PE as defined by ESC guidelines1
- •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 commercially available are not considered investigational studies
- •Other medical, social, 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
研究组 & 干预措施
CAVT thrombectomy
PE with evidence of right heart strain and thrombectomy with 16Fr CAVT
PE with evidence of right heart strain
PE with evidence of right heart strain
结局指标
主要结局
LV/RV ratio
时间窗: 48 (+ 48 /- 24) hours post procedure.
1\. To evaluate the effectiveness of PE CAVT as a treatment for intermediate and high-risk PE as measured by change pulmonary arterial pressure and in RV/LV (Right Ventricle to Left Ventricle diameter) ratio at 48 (+ 48 /- 24) hours post procedure.
Morbidity and mortality
时间窗: within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).
Ascertain the mortality and morbidity profile for CAVT within intermediate and high-risk PE, within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).
次要结局
未报告次要终点