A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy
- Conditions
- Pulmonary Embolism
- Interventions
- Device: Pharmacodynamic thrombectomy
- Registration Number
- NCT04318782
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Thrombectomy Pharmacodynamic thrombectomy Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter
- Primary Outcome Measures
Name Time Method Survival rate one month Survival rate at one month
- Secondary Outcome Measures
Name Time Method Cumulative rate of patients requiring a surgical pulmonary thrombectomy 30 days Cumulative rate of patients requiring a surgical pulmonary thrombectomy at 30 days
Modification of the ratio of right/left ventricle diameter 48 hours Modification of the ratio of right/left ventricle diameter at 48 hours
Length of stay in the intensive care unit 30 days Length of stay in the intensive care unit
Major bleeding rate 30 days Major bleeding rate at 30 days
Thromboembolic recurrence rate 30 days Objectively confirmed thromboembolic recurrence rate at 30 days
Clinical success rate 30 days Clinical success rate at 30 days
Pulmonary Embolism mortality 30 days Pulmonary Embolism mortality at 30 days
Results of coagulation / fibrinolysis markers 30 days Results of coagulation / fibrinolysis markers at 30 days
Global mortality 30 days Global mortality at 30 days
Clinically significant non-major bleeding 30 days Clinically significant non-major bleeding at 30 days
Description of AE/SAE 30 days Description of AE/SAE at 30 days
Length of hospital stay 30 days Length of hospital stay
Modification of the scanographic pulmonary vascular obstruction score 48 hours Modification of the scanographic pulmonary vascular obstruction score at 48 hours
Trial Locations
- Locations (1)
AP-HP - Hôpital Européen Georges-Pompidou Paris
🇫🇷Paris, Ile-de-France, France