A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Device: Pharmacodynamic thrombectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thrombectomy<br>Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter | Device: Pharmacodynamic thrombectomy<br>* Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Survival rate at one month | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global mortality | Global mortality at 7 days | 7 days | 
| Global mortality | Global mortality at 30 days | 30 days | 
| Pulmonary Embolism mortality | Pulmonary Embolism mortality at 7 days | 7 days | 
| Pulmonary Embolism mortality | Pulmonary Embolism mortality at 30 days | 30 days | 
| Major bleeding rate | Major bleeding rate at 7 days | 7 days | 
| Major bleeding rate | Major bleeding rate at 30 days | 30 days | 
| Clinically significant non-major bleeding | Clinically significant non-major bleeding at 7 days | 7 days | 
| Clinically significant non-major bleeding | Clinically significant non-major bleeding at 30 days | 30 days | 
| Thromboembolic recurrence rate | Objectively confirmed thromboembolic recurrence rate at 7 days | 7 days | 
| Thromboembolic recurrence rate | Objectively confirmed thromboembolic recurrence rate at 30 days | 30 days | 
| Cumulative rate of patients requiring a surgical pulmonary thrombectomy | Cumulative rate of patients requiring a surgical pulmonary thrombectomy at 7 days | 7 days | 
| Cumulative rate of patients requiring a surgical pulmonary thrombectomy | Cumulative rate of patients requiring a surgical pulmonary thrombectomy at 30 days | 30 days | 
| Clinical success rate | Clinical success rate at 7 days | 7 days | 
| Clinical success rate | Clinical success rate at 30 days | 30 days | 
| Description of AE/SAE | Description of AE/SAE at 30 days | 30 days | 
| Modification of the ratio of right/left ventricle diameter | Modification of the ratio of right/left ventricle diameter at 48 hours | 48 hours | 
| Modification of the scanographic pulmonary vascular obstruction score | Modification of the scanographic pulmonary vascular obstruction score at 48 hours | 48 hours | 
| Results of coagulation / fibrinolysis markers | Results of coagulation / fibrinolysis markers at 7 days | 7 days | 
| Results of coagulation / fibrinolysis markers | Results of coagulation / fibrinolysis markers at 30 days | 30 days | 
| Length of hospital stay | Length of hospital stay | 30 days | 
| Length of stay in the intensive care unit | Length of stay in the intensive care unit | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary embolism, pharmacodynamic thrombectomy, endovascular embolectomy