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

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.

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

Individual participant data that underlie results in publication could be shared Individual participant data detailed in meta analysis protocol could be shared

Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization