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

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Pulmonary Embolism

Treatments

Device: Pharmacodynamic thrombectomy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04318782

2019-A01627-50 (Other Identifier)

P171007J

DR-2019-329 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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