A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Survival rate
研究概览
简要总结
The mortality of severe pulmonary embolisms admitted to the resuscitation department for circulatory failure remains in the range of 30-40% at the acute phase. Hemodynamic failure is the leading cause of death. These patients frequently have a contraindication to thrombolysis. Surgical pulmonary arterial desobstruction still leads to significant hospital mortality and can't be implemented in all hospitals. Concerning advanced hemodynamic support techniques, they can't always reduce mortality on themselves. There is therefore a need for developing alternative approaches for less invasive pulmonary arterial desobstruction. Data on the efficacy and safety of percutaneous methods of desobstruction are still too limited to implement them in current practice.
AngioJet ™ PE is a device CE marked for intra-arterial desobstruction of pulmonary arteries. It has been successfully tested in more than 25 patients with pulmonary embolism in France. Before considering a request for reimbursement from the HAS it is necessary to have propective data of sufficient quality. This phase 2a prospective study is proposed to evaluate the efficacy and safety of the AngioJet ™ PE catheter use. The resulting data will allow us to submit a Phase 3 controlled study to an upcoming PHRC-type project call.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulmonary embolism objectively confirmed by thoracic angioTDM
- •Date of onset of pulmonary embolism 14 days prior to inclusion
- •State of shock
- •Presence of at least 6 mm thrombus in a main or lobar pulmonary artery
- •Contraindication (absolute or relative) or systemic fibrinolysis treatment failure defined by persistence of shock, as defined above, more than 6 hours
排除标准
- •Known cardiac pathologies with right-left cardiac shunt
- •Target pulmonary artery 6 mm in diameter
- •Known heparin allergy or thrombocytopenia
- •Known severe hypersensitivity to iodine contrast products
- •Severe renal failure defined by creatinine clearance 30 ml/min Pregnant or lactating patient
- •Patient not affiliated to social security
- •Patient with unhealed lesion due to recent mechanical intervention on the vessel to be treated
结局指标
主要结局
Survival rate
时间窗: one month
Survival rate at one month
次要结局
- Major bleeding rate(30 days)
- Cumulative rate of patients requiring a surgical pulmonary thrombectomy(30 days)
- Modification of the ratio of right/left ventricle diameter(48 hours)
- Length of stay in the intensive care unit(30 days)
- Thromboembolic recurrence rate(30 days)
- Clinical success rate(30 days)
- Pulmonary Embolism mortality(30 days)
- Results of coagulation / fibrinolysis markers(30 days)
- Global mortality(30 days)
- Clinically significant non-major bleeding(30 days)
- Description of AE/SAE(30 days)
- Length of hospital stay(30 days)
- Modification of the scanographic pulmonary vascular obstruction score(48 hours)