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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: Pharmacodynamic thrombectomy

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GOUDE-ORY Karine; Phone Number: 00331 44 84 17 22; Email: karine.goude@aphp.fr
• Study Contact Backup: Name: MANSEUR Hakima, MSc; Phone Number: 00331 56 09 59 71; Email: hakima.manseur@aphp.fr

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75015
      • Recruiting
      • AP-HP - Hôpital Européen Georges-Pompidou Paris
      • Contact: Sanchez Olivier; Phone Number: 00331 56 09 34 61; Email: olivier.sanchez@aphp.fr
      • Contact: DEAN Carole; Phone Number: 00331 56 09 37 19; Email: carole.dean@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thrombectomy; Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter	Device: Pharmacodynamic thrombectomy; Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	Survival rate at one month	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global mortality	Global mortality at 7 days	7 days
Global mortality	Global mortality at 30 days	30 days
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: DEL GIUDICE Costantino, MD, PhD, Assistance Publique Hopitaux de Paris (APHP)

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Anticipated): February 10, 2021
• Study Completion (Anticipated): February 10, 2021

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: pulmonary embolism; pharmacodynamic thrombectomy; endovascular embolectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: P171007J; 2019-A01627-50 (Other Identifier: ANSM); DR-2019-329 (Other Identifier: CNIL)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie results in publication could be shared Individual participant data detailed in meta analysis protocol could be shared
• IPD Sharing Time Frame: One year after the last publication

IPD Sharing 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

• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No