Status:
UNKNOWN
A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18-90 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 10 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04318782
Start Date
February 10 2020
End Date
February 10 2021
Last Update
March 24 2020
Active Locations (1)
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1
AP-HP - Hôpital Européen Georges-Pompidou Paris
Paris, Île-de-France Region, France, 75015