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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter
AP-HP - Hôpital Européen Georges-Pompidou Paris
Paris, Île-de-France Region, France
RECRUITINGSurvival rate
Survival rate at one month
Time frame: one month
Global mortality
Global mortality at 7 days
Time frame: 7 days
Global mortality
Global mortality at 30 days
Time frame: 30 days
Pulmonary Embolism mortality
Pulmonary Embolism mortality at 7 days
Time frame: 7 days
Pulmonary Embolism mortality
Pulmonary Embolism mortality at 30 days
Time frame: 30 days
Major bleeding rate
Major bleeding rate at 7 days
Time frame: 7 days
Major bleeding rate
Major bleeding rate at 30 days
Time frame: 30 days
Clinically significant non-major bleeding
Clinically significant non-major bleeding at 7 days
Time frame: 7 days
Clinically significant non-major bleeding
Clinically significant non-major bleeding at 30 days
Time frame: 30 days
Thromboembolic recurrence rate
Objectively confirmed thromboembolic recurrence rate at 7 days
Time frame: 7 days
Thromboembolic recurrence rate
Objectively confirmed thromboembolic recurrence rate at 30 days
Time frame: 30 days
Cumulative rate of patients requiring a surgical pulmonary thrombectomy
Cumulative rate of patients requiring a surgical pulmonary thrombectomy at 7 days
Time frame: 7 days
Cumulative rate of patients requiring a surgical pulmonary thrombectomy
Cumulative rate of patients requiring a surgical pulmonary thrombectomy at 30 days
Time frame: 30 days
Clinical success rate
Clinical success rate at 7 days
Time frame: 7 days
Clinical success rate
Clinical success rate at 30 days
Time frame: 30 days
Description of AE/SAE
Description of AE/SAE at 30 days
Time frame: 30 days
Modification of the ratio of right/left ventricle diameter
Modification of the ratio of right/left ventricle diameter at 48 hours
Time frame: 48 hours
Modification of the scanographic pulmonary vascular obstruction score
Modification of the scanographic pulmonary vascular obstruction score at 48 hours
Time frame: 48 hours
Results of coagulation / fibrinolysis markers
Results of coagulation / fibrinolysis markers at 7 days
Time frame: 7 days
Results of coagulation / fibrinolysis markers
Results of coagulation / fibrinolysis markers at 30 days
Time frame: 30 days
Length of hospital stay
Length of hospital stay
Time frame: 30 days
Length of stay in the intensive care unit
Length of stay in the intensive care unit
Time frame: 30 days
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