Clinical trial NCT04318782: A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy
Official title: A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Embolism
Keywords: pulmonary embolism
pharmacodynamic thrombectomy
endovascular embolectomy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2020-03-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Survival rate
timeFrame: one month
Secondary outcomes:
measure: Global mortality
timeFrame: 7 days
measure: Global mortality
timeFrame: 30 days
measure: Pulmonary Embolism mortality
timeFrame: 7 days
measure: Pulmonary Embolism mortality
timeFrame: 30 days
measure: Major bleeding rate
timeFrame: 7 days
measure: Major bleeding rate
timeFrame: 30 days
measure: Clinically significant non-major bleeding
timeFrame: 7 days
measure: Clinically significant non-major bleeding
timeFrame: 30 days
measure: Thromboembolic recurrence rate
timeFrame: 7 days
measure: Thromboembolic recurrence rate
timeFrame: 30 days
measure: Cumulative rate of patients requiring a surgical pulmonary thrombectomy
timeFrame: 7 days
measure: Cumulative rate of patients requiring a surgical pulmonary thrombectomy
timeFrame: 30 days
measure: Clinical success rate
timeFrame: 7 days
measure: Clinical success rate
timeFrame: 30 days
measure: Description of AE/SAE
timeFrame: 30 days
measure: Modification of the ratio of right/left ventricle diameter
timeFrame: 48 hours
measure: Modification of the scanographic pulmonary vascular obstruction score
timeFrame: 48 hours
measure: Results of coagulation / fibrinolysis markers
timeFrame: 7 days
measure: Results of coagulation / fibrinolysis markers
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
measure: Length of stay in the intensive care unit
timeFrame: 30 days
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP - Hôpital Européen Georges-Pompidou Paris
state: Ile-de-France
Study officials:
affiliation: Assistance Publique Hopitaux de Paris (APHP)
name: DEL GIUDICE Costantino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: