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

NCT ID: NCT04318782

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-10
• Study Completion Date: 2021-02-10

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.

Conditions

Pulmonary Embolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thrombectomy

Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter

Group Type: EXPERIMENTAL

Pharmacodynamic thrombectomy

Intervention Type: DEVICE

Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter

Interventions

Pharmacodynamic thrombectomy

Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

DEL GIUDICE Costantino, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hopitaux de Paris (APHP)

Locations

AP-HP - Hôpital Européen Georges-Pompidou Paris

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

GOUDE-ORY Karine

Role: CONTACT

karine.goude@aphp.fr

00331 44 84 17 22

MANSEUR Hakima, MSc

Role: CONTACT

hakima.manseur@aphp.fr

00331 56 09 59 71

Facility Contacts

Sanchez Olivier

Role: primary

olivier.sanchez@aphp.fr

00331 56 09 34 61

DEAN Carole

Role: backup

carole.dean@aphp.fr

00331 56 09 37 19

Other Identifiers

2019-A01627-50

Identifier Type: OTHER

Identifier Source: secondary_id

DR-2019-329

Identifier Type: OTHER

Identifier Source: secondary_id

P171007J

Identifier Type: -

Identifier Source: org_study_id