NCT04318782

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2021

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 20, 2020

Last Update Submit

March 20, 2020

Conditions

Pulmonary Embolism

Keywords

pulmonary embolismpharmacodynamic thrombectomyendovascular embolectomy

Outcome Measures

Primary Outcomes (1)

  • Survival rate

    Survival rate at one month

    one month

Secondary Outcomes (21)

  • Global mortality

    7 days

  • Global mortality

    30 days

  • Pulmonary Embolism mortality

    7 days

  • Pulmonary Embolism mortality

    30 days

  • Major bleeding rate

    7 days

  • +16 more secondary outcomes

Study Arms (1)

Thrombectomy

EXPERIMENTAL

Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter

Device: Pharmacodynamic thrombectomy

Interventions

Pharmacodynamic thrombectomyDEVICE

Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter

Thrombectomy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pulmonary embolism objectively confirmed by thoracic angioTDM
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP - Hôpital Européen Georges-Pompidou Paris

Paris, Île-de-France Region, 75015, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • DEL GIUDICE Costantino, MD, PhD

    Assistance Publique Hopitaux de Paris (APHP)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GOUDE-ORY Karine

CONTACT

00331 44 84 17 22karine.goude@aphp.fr

MANSEUR Hakima, MSc

CONTACT

00331 56 09 59 71hakima.manseur@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2020

First Posted

March 24, 2020

Study Start

February 10, 2020

Primary Completion

February 10, 2021

Study Completion

February 10, 2021

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie results in publication could be shared Individual participant data detailed in meta analysis protocol could be shared

Shared Documents
STUDY PROTOCOL, 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

Locations

FR(1)