Pulmonary Embolism
Conditions
Keywords
pulmonary embolism, pharmacodynamic thrombectomy, endovascular embolectomy
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.
Interventions
DEVICEPharmacodynamic thrombectomy
Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter
Sponsors
Boston Scientific Corporation
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | one month | Survival rate at one month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Embolism mortality | 7 days | Pulmonary Embolism mortality at 7 days |
| Major bleeding rate | 7 days | Major bleeding rate at 7 days |
| Clinically significant non-major bleeding | 7 days | Clinically significant non-major bleeding at 7 days |
| Thromboembolic recurrence rate | 7 days | Objectively confirmed thromboembolic recurrence rate at 7 days |
| Cumulative rate of patients requiring a surgical pulmonary thrombectomy | 7 days | Cumulative rate of patients requiring a surgical pulmonary thrombectomy at 7 days |
| Clinical success rate | 7 days | Clinical success rate at 7 days |
| Global mortality | 7 days | Global mortality at 7 days |
| Modification of the ratio of right/left ventricle diameter | 48 hours | Modification of the ratio of right/left ventricle diameter at 48 hours |
| Modification of the scanographic pulmonary vascular obstruction score | 48 hours | Modification of the scanographic pulmonary vascular obstruction score at 48 hours |
| Results of coagulation / fibrinolysis markers | 7 days | Results of coagulation / fibrinolysis markers at 7 days |
| Length of hospital stay | 30 days | Length of hospital stay |
| Length of stay in the intensive care unit | 30 days | Length of stay in the intensive care unit |
| Description of AE/SAE | 30 days | Description of AE/SAE at 30 days |
Countries
France
Contacts
Primary ContactGOUDE-ORY Karine
Backup ContactMANSEUR Hakima, MSc
Outcome results
None listed