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

Pulmonary Embolism Clinical Trial

— RESPIRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04318782
• Other study ID #: P171007J
• Secondary ID: 2019-A01627-50DR
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: March 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: GOUDE-ORY Karine
• Phone: 00331 44 84 17 22
• Email: karine.goude[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• Pharmacodynamic thrombectomy
Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter

Locations

Country	Name	City	State
France	AP-HP - Hôpital Européen Georges-Pompidou Paris	Paris	Ile-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Boston Scientific Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	Survival rate at one month	one month
Secondary	Global mortality	Global mortality at 7 days	7 days
Secondary	Global mortality	Global mortality at 30 days	30 days
Secondary	Pulmonary Embolism mortality	Pulmonary Embolism mortality at 7 days	7 days
Secondary	Pulmonary Embolism mortality	Pulmonary Embolism mortality at 30 days	30 days
Secondary	Major bleeding rate	Major bleeding rate at 7 days	7 days
Secondary	Major bleeding rate	Major bleeding rate at 30 days	30 days
Secondary	Clinically significant non-major bleeding	Clinically significant non-major bleeding at 7 days	7 days
Secondary	Clinically significant non-major bleeding	Clinically significant non-major bleeding at 30 days	30 days
Secondary	Thromboembolic recurrence rate	Objectively confirmed thromboembolic recurrence rate at 7 days	7 days
Secondary	Thromboembolic recurrence rate	Objectively confirmed thromboembolic recurrence rate at 30 days	30 days
Secondary	Cumulative rate of patients requiring a surgical pulmonary thrombectomy	Cumulative rate of patients requiring a surgical pulmonary thrombectomy at 7 days	7 days
Secondary	Cumulative rate of patients requiring a surgical pulmonary thrombectomy	Cumulative rate of patients requiring a surgical pulmonary thrombectomy at 30 days	30 days
Secondary	Clinical success rate	Clinical success rate at 7 days	7 days
Secondary	Clinical success rate	Clinical success rate at 30 days	30 days
Secondary	Description of AE/SAE	Description of AE/SAE at 30 days	30 days
Secondary	Modification of the ratio of right/left ventricle diameter	Modification of the ratio of right/left ventricle diameter at 48 hours	48 hours
Secondary	Modification of the scanographic pulmonary vascular obstruction score	Modification of the scanographic pulmonary vascular obstruction score at 48 hours	48 hours
Secondary	Results of coagulation / fibrinolysis markers	Results of coagulation / fibrinolysis markers at 7 days	7 days
Secondary	Results of coagulation / fibrinolysis markers	Results of coagulation / fibrinolysis markers at 30 days	30 days
Secondary	Length of hospital stay	Length of hospital stay	30 days
Secondary	Length of stay in the intensive care unit	Length of stay in the intensive care unit	30 days