Pulmonary Embolism Clinical Trial
Official title:
A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy
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.
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