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A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy (RESPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318782
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Pulmonary Embolism Device: Pharmacodynamic thrombectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : February 10, 2021
Estimated Study Completion Date : February 10, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Thrombectomy
Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter
Device: Pharmacodynamic thrombectomy
Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter




Primary Outcome Measures :
  1. Survival rate [ Time Frame: one month ]
    Survival rate at one month


Secondary Outcome Measures :
  1. Global mortality [ Time Frame: 7 days ]
    Global mortality at 7 days

  2. Global mortality [ Time Frame: 30 days ]
    Global mortality at 30 days

  3. Pulmonary Embolism mortality [ Time Frame: 7 days ]
    Pulmonary Embolism mortality at 7 days

  4. Pulmonary Embolism mortality [ Time Frame: 30 days ]
    Pulmonary Embolism mortality at 30 days

  5. Major bleeding rate [ Time Frame: 7 days ]
    Major bleeding rate at 7 days

  6. Major bleeding rate [ Time Frame: 30 days ]
    Major bleeding rate at 30 days

  7. Clinically significant non-major bleeding [ Time Frame: 7 days ]
    Clinically significant non-major bleeding at 7 days

  8. Clinically significant non-major bleeding [ Time Frame: 30 days ]
    Clinically significant non-major bleeding at 30 days

  9. Thromboembolic recurrence rate [ Time Frame: 7 days ]
    Objectively confirmed thromboembolic recurrence rate at 7 days

  10. Thromboembolic recurrence rate [ Time Frame: 30 days ]
    Objectively confirmed thromboembolic recurrence rate at 30 days

  11. Cumulative rate of patients requiring a surgical pulmonary thrombectomy [ Time Frame: 7 days ]
    Cumulative rate of patients requiring a surgical pulmonary thrombectomy at 7 days

  12. Cumulative rate of patients requiring a surgical pulmonary thrombectomy [ Time Frame: 30 days ]
    Cumulative rate of patients requiring a surgical pulmonary thrombectomy at 30 days

  13. Clinical success rate [ Time Frame: 7 days ]
    Clinical success rate at 7 days

  14. Clinical success rate [ Time Frame: 30 days ]
    Clinical success rate at 30 days

  15. Description of AE/SAE [ Time Frame: 30 days ]
    Description of AE/SAE at 30 days

  16. Modification of the ratio of right/left ventricle diameter [ Time Frame: 48 hours ]
    Modification of the ratio of right/left ventricle diameter at 48 hours

  17. Modification of the scanographic pulmonary vascular obstruction score [ Time Frame: 48 hours ]
    Modification of the scanographic pulmonary vascular obstruction score at 48 hours

  18. Results of coagulation / fibrinolysis markers [ Time Frame: 7 days ]
    Results of coagulation / fibrinolysis markers at 7 days

  19. Results of coagulation / fibrinolysis markers [ Time Frame: 30 days ]
    Results of coagulation / fibrinolysis markers at 30 days

  20. Length of hospital stay [ Time Frame: 30 days ]
    Length of hospital stay

  21. Length of stay in the intensive care unit [ Time Frame: 30 days ]
    Length of stay in the intensive care unit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318782


Contacts
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Contact: GOUDE-ORY Karine 00331 44 84 17 22 karine.goude@aphp.fr
Contact: MANSEUR Hakima, MSc 00331 56 09 59 71 hakima.manseur@aphp.fr

Locations
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France
AP-HP - Hôpital Européen Georges-Pompidou Paris Recruiting
Paris, Ile-de-France, France, 75015
Contact: Sanchez Olivier    00331 56 09 34 61    olivier.sanchez@aphp.fr   
Contact: DEAN Carole    00331 56 09 37 19    carole.dean@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Boston Scientific Corporation
Investigators
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Principal Investigator: DEL GIUDICE Costantino, MD, PhD Assistance Publique Hopitaux de Paris (APHP)
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04318782    
Other Study ID Numbers: P171007J
2019-A01627-50 ( Other Identifier: ANSM )
DR-2019-329 ( Other Identifier: CNIL )
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie results in publication could be shared Individual participant data detailed in meta analysis protocol could be shared
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: One year after the last publication
Access Criteria:

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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
pulmonary embolism
pharmacodynamic thrombectomy
endovascular embolectomy
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases