Pulmonary EmbolismRESPIRENCT04318782
A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy
A study testing Pharmacodynamic thrombectomy in people with Pulmonary Embolism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Pharmacodynamic thrombectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2020to 10 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
AP-HP - Hôpital Européen Georges-Pompidou Paris
Paris, Île-de-France Region, 75015
Sanchez Olivier, 00331 56 09 34 61, olivier.sanchez@aphp.fr
DEAN Carole, 00331 56 09 37 19, carole.dean@aphp.fr
About this study
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
- Being tested
- Pharmacodynamic thrombectomy
- Keywords
- pulmonary embolism, pharmacodynamic thrombectomy, endovascular embolectomy
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacodynamic thrombectomyDevice
Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter
| Study group | Role | What they receive |
|---|---|---|
| Thrombectomy | Experimental | Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter Receives: Device: Pharmacodynamic thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Survival rate at one month
Measured: one month
Secondary outcomes (21)
Global mortality
Global mortality at 7 days
Measured: 7 days
Global mortality
Global mortality at 30 days
Measured: 30 days
Pulmonary Embolism mortality
Pulmonary Embolism mortality at 7 days
Measured: 7 days
Pulmonary Embolism mortality
Pulmonary Embolism mortality at 30 days
Measured: 30 days
Major bleeding rate
Major bleeding rate at 7 days
Measured: 7 days
Major bleeding rate
Major bleeding rate at 30 days
Measured: 30 days
Clinically significant non-major bleeding
Clinically significant non-major bleeding at 7 days
Measured: 7 days
Clinically significant non-major bleeding
Clinically significant non-major bleeding at 30 days
Measured: 30 days
Thromboembolic recurrence rate
Objectively confirmed thromboembolic recurrence rate at 7 days
Measured: 7 days
Thromboembolic recurrence rate
Objectively confirmed thromboembolic recurrence rate at 30 days
Measured: 30 days
Cumulative rate of patients requiring a surgical pulmonary thrombectomy
Cumulative rate of patients requiring a surgical pulmonary thrombectomy at 7 days
Measured: 7 days
Cumulative rate of patients requiring a surgical pulmonary thrombectomy
Cumulative rate of patients requiring a surgical pulmonary thrombectomy at 30 days
Measured: 30 days
Clinical success rate
Clinical success rate at 7 days
Measured: 7 days
Clinical success rate
Clinical success rate at 30 days
Measured: 30 days
Description of AE/SAE
Description of AE/SAE at 30 days
Measured: 30 days
Modification of the ratio of right/left ventricle diameter
Modification of the ratio of right/left ventricle diameter at 48 hours
Measured: 48 hours
Modification of the scanographic pulmonary vascular obstruction score
Modification of the scanographic pulmonary vascular obstruction score at 48 hours
Measured: 48 hours
Results of coagulation / fibrinolysis markers
Results of coagulation / fibrinolysis markers at 7 days
Measured: 7 days
Results of coagulation / fibrinolysis markers
Results of coagulation / fibrinolysis markers at 30 days
Measured: 30 days
Length of hospital stay
Length of hospital stay
Measured: 30 days
Length of stay in the intensive care unit
Length of stay in the intensive care unit
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start10 Feb 2020
- Primary completion10 Feb 2021 (estimated)
- Study completion10 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- DEL GIUDICE Costantino, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318782
- Sponsor's protocol ID
- P171007J
- Other IDs
- 2019-A01627-50, DR-2019-329
- Acronym
- RESPIRE
- Status last verified
- Mar 2020
- First submitted
- 20 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in publication could be shared Individual participant data detailed in meta analysis protocol could be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy
- ClinicalTrials.gov ID
- NCT04318782
- Acronym / sponsor ID
- RESPIRE / P171007J
- Conditions
- Pulmonary Embolism
- Keywords
- pulmonary embolism, pharmacodynamic thrombectomy, endovascular embolectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 10 Feb 2021 (estimated)
- Study completion
- 10 Feb 2021 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thrombectomy | Experimental | Device: Pharmacodynamic thrombectomyPharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacodynamic thrombectomyPharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter | Device | Thrombectomy |
Primary outcome
Survival rate
Time frame: one month
Survival rate at one month
21 secondary outcomes
Global mortality
Time frame: 7 days
Global mortality
Time frame: 30 days
Pulmonary Embolism mortality
Time frame: 7 days
Pulmonary Embolism mortality
Time frame: 30 days
Major bleeding rate
Time frame: 7 days
Major bleeding rate
Time frame: 30 days
Clinically significant non-major bleeding
Time frame: 7 days
Clinically significant non-major bleeding
Time frame: 30 days
Thromboembolic recurrence rate
Time frame: 7 days
Thromboembolic recurrence rate
Time frame: 30 days
Cumulative rate of patients requiring a surgical pulmonary thrombectomy
Time frame: 7 days
Cumulative rate of patients requiring a surgical pulmonary thrombectomy
Time frame: 30 days
Clinical success rate
Time frame: 7 days
Clinical success rate
Time frame: 30 days
Description of AE/SAE
Time frame: 30 days
Modification of the ratio of right/left ventricle diameter
Time frame: 48 hours
Modification of the scanographic pulmonary vascular obstruction score
Time frame: 48 hours
Results of coagulation / fibrinolysis markers
Time frame: 7 days
Results of coagulation / fibrinolysis markers
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
Length of stay in the intensive care unit
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in publication could be shared Individual participant data detailed in meta analysis protocol could be shared
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DEL GIUDICE Costantino, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacodynamic thrombectomy in people with Pulmonary Embolism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GOUDE-ORY Karine (00331 44 84 17 22, karine.goude@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.