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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01627-50 | Other Identifier | ANSM | |
| DR-2019-329 | Other Identifier | CNIL |
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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 â„¢ 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 â„¢ 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thrombectomy | Experimental | Pharmacodynamic thrombectomy using AngioJet â„¢ PE Thrombectomy Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacodynamic thrombectomy | Device | Pharmacodynamic thrombectomy using AngioJet â„¢ PE Thrombectomy Catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | Survival rate at one month | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Global mortality | Global mortality at 7 days | 7 days |
| Global mortality | Global mortality at 30 days | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GOUDE-ORY Karine | Contact | 00331 44 84 17 22 | karine.goude@aphp.fr | |
| MANSEUR Hakima, MSc | Contact | 00331 56 09 59 71 | hakima.manseur@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| DEL GIUDICE Costantino, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP - Hôpital Européen Georges-Pompidou Paris | Recruiting | Paris | Île-de-France Region | 75015 | France |
Individual participant data that underlie results in publication could be shared Individual participant data detailed in meta analysis protocol could be shared
One year after the last publication
Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team.
Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| Pulmonary Embolism mortality | Pulmonary Embolism mortality at 7 days | 7 days |
| Pulmonary Embolism mortality | Pulmonary Embolism mortality at 30 days | 30 days |
| Major bleeding rate | Major bleeding rate at 7 days | 7 days |
| Major bleeding rate | Major bleeding rate at 30 days | 30 days |
| Clinically significant non-major bleeding | Clinically significant non-major bleeding at 7 days | 7 days |
| Clinically significant non-major bleeding | Clinically significant non-major bleeding at 30 days | 30 days |
| Thromboembolic recurrence rate | Objectively confirmed thromboembolic recurrence rate at 7 days | 7 days |
| Thromboembolic recurrence rate | Objectively confirmed thromboembolic recurrence rate at 30 days | 30 days |
| Cumulative rate of patients requiring a surgical pulmonary thrombectomy | Cumulative rate of patients requiring a surgical pulmonary thrombectomy at 7 days | 7 days |
| Cumulative rate of patients requiring a surgical pulmonary thrombectomy | Cumulative rate of patients requiring a surgical pulmonary thrombectomy at 30 days | 30 days |
| Clinical success rate | Clinical success rate at 7 days | 7 days |
| Clinical success rate | Clinical success rate at 30 days | 30 days |
| Description of AE/SAE | Description of AE/SAE at 30 days | 30 days |
| Modification of the ratio of right/left ventricle diameter | Modification of the ratio of right/left ventricle diameter at 48 hours | 48 hours |
| Modification of the scanographic pulmonary vascular obstruction score | Modification of the scanographic pulmonary vascular obstruction score at 48 hours | 48 hours |
| Results of coagulation / fibrinolysis markers | Results of coagulation / fibrinolysis markers at 7 days | 7 days |
| Results of coagulation / fibrinolysis markers | Results of coagulation / fibrinolysis markers at 30 days | 30 days |
| Length of hospital stay | Length of hospital stay | 30 days |
| Length of stay in the intensive care unit | Length of stay in the intensive care unit | 30 days |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |