Pulmonary EmbolismPhase 4PERFUSENCT01638468
Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra System
A Phase 4 study testing AngioJet Ultra PE Thrombectomy System in people with Pulmonary Embolism, run by Boston Scientific Corporation at 7 sites in 4 countries.
Trial summary
The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety, efficacy, adverse events and any new information that may surface regarding the use of the AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main pulmonary and lobar arteries ≥ 6mm in diameter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- AngioJet Ultra PE Thrombectomy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Jan 2013to Jan 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic pulmonary embolism patients >18 years
- Availability of a baseline contrast-enhanced chest computed tomogram or conventional pulmonary angiogram with evidence of pulmonary embolus in at least one main or lobar pulmonary artery ≥ 6mm in diameter
- Availability of a baseline transthoracic echocardiogram with sufficient image quality permitting the measurement of right ventricular (RV) and left ventricular (LV) dimensions in the apical or subcostal four-chamber view
- Echocardiographic evidence of right ventricular dilatation with a subannular RV/LV ratio ≥ 0.9 from the apical or subcostal four-chamber view
- Appropriate informed consent was obtained from the patient or legal representative
Who cannot join
- Patient has underwent Cardiopulmonary Resuscitation (CPR) in the last 48 hours
- Patient is participating in any other clinical study
- Pregnancy, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested or use a medically accepted method of birth control)
- Inability to comply with study Follow-up assessments (e.g. due to geographic)
- Previous enrollment in this study
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Italy4 sites
EO Ospedali Galliera - Genova
Genova, 16128
Universita Federico II di Napoli
Naples, 80131
Ospedale S. Maria Delle Croci
Ravenna
Ospedale Sant' Anna Di Como
San Fermo della Battaglia, 22020
Portugal1 site
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, 4434-502
About this study
Official title: Pulmonary Embolism Removal With the AngioJet 6F Ultra SystEm (PERFUSE)
The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety, efficacy, adverse events and any new information that may surface regarding the use of the AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main pulmonary and lobar arteries ≥ 6mm in diameter.
Read the detailed description
Despite advances in prophylaxis, diagnostic modalities, and therapeutic options, pulmonary embolism remains a commonly under diagnosed and lethal entity. In the United States approximately 150,000 patients per year are diagnosed with acute pulmonary embolisms. Many additional deaths occur each year in the United States as a result of undiagnosed massive pulmonary embolisms. Taking these patients into account, it is thought that up to 600,000 patients develop a pulmonary embolism annually in this country. In patients with acute pulmonary embolism, the most common cause of early death is right ventricular failure.
In addition to anticoagulation therapy, several reperfusion therapies are being used to reverse right ventricular failure: systemic thrombolysis, surgical embolectomy, and catheter based therapy. Given the drawbacks of systemic thrombolytic therapy or surgical embolectomy, percutaneous catheter treatment is a reasonable alternative for patients with contraindications to systemic thrombolytic therapy or surgery. Current international consensus guidelines support the use of catheter interventions for selected pulmonary embolism patients at increased risk of adverse clinical outcomes.
The AngioJet Ultra PE Thrombectomy catheter introduces a pressurized high velocity saline stream through a catheter tip so that the clot within a blood vessel is trapped, broken into small pieces and aspirated from the body.
- Conditions
- Pulmonary Embolism
- Being tested
- AngioJet Ultra PE Thrombectomy System
- Keywords
- Pulmonary Embolism, Acute Pulmonary Embolism, Sub-massive Pulmonary Embolism, Massive Pulmonary Embolism, Pulmonary Thromboembolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioJet Ultra PE Thrombectomy SystemDevice
Also called AngioJet
Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
| Study group | Role | What they receive |
|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Experimental | Patients are treated with the AngioJet Ultra PE Thrombectomy System Receives: Device: AngioJet Ultra PE Thrombectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography
The change in the subannular end-diastolic RV/LV ratio at 24-48 hrs following thrombectomy compared to baseline measurements as assessed by an independent core lab analysis. RV and LV values will be measured by echocardiography, a technique utilizing ultrasound waves to assess heart activity.
Measured: Baseline to 24-48 hours
Secondary outcomes (10)
Technical Success
Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure
Measured: Index Procedure
Death - All Cause
Number of participant deaths due to any reason occurring within 3 months of the index procedure.
Measured: 3 months
Death - Cardiac Cause
Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure.
Measured: 3 months
Change in Systolic Pulmonary Arterial Blood Pressure
Change in systolic pulmonary arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.
Measured: Baseline to Post Index Procedure
Pulmonary Systolic Arterial Blood Pressure
Pulmonary systolic arterial blood pressure at termination of the index procedure.
Measured: Post Index Procedure
Change in Systemic Systolic Arterial Blood Pressure
Change in systemic systolic arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.
Measured: Baseline to Post Index Procedure
Systemic Systolic Arterial Blood Pressure
Systemic systolic arterial blood pressure at termination of the index procedure.
Measured: Post Index Procedure
Change in Heart Rate
Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment.
Measured: Baseline to Post Index Procedure
Vasopressor Support
Percentage of participants receiving vasopressor support during the index procedure. Vasopressor support are medications administered to prevent the narrowing of blood vessels.
Measured: Index Procedure
Procedure Related Adverse Event Rate
Number of procedure related adverse events occurring within 3 months of the index procedure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Slow Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nils Kucher, Prof Dr Med, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638468
- Sponsor's protocol ID
- PERFUSE
- Acronym
- PERFUSE
- Status last verified
- Nov 2018
- First submitted
- 6 Jul 2012
- Last updated
- 5 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Embolism Removal With the AngioJet 6F Ultra SystEm (PERFUSE)
- ClinicalTrials.gov ID
- NCT01638468
- Acronym / sponsor ID
- PERFUSE / PERFUSE
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Acute Pulmonary Embolism, Sub-massive Pulmonary Embolism, Massive Pulmonary Embolism, Pulmonary Thromboembolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Posted 1 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety, efficacy, adverse events and any new information that may surface regarding the use of the AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main pulmonary and lobar arteries ≥ 6mm in diameter.
Detailed description
Despite advances in prophylaxis, diagnostic modalities, and therapeutic options, pulmonary embolism remains a commonly under diagnosed and lethal entity. In the United States approximately 150,000 patients per year are diagnosed with acute pulmonary embolisms. Many additional deaths occur each year in the United States as a result of undiagnosed massive pulmonary embolisms. Taking these patients into account, it is thought that up to 600,000 patients develop a pulmonary embolism annually in this country. In patients with acute pulmonary embolism, the most common cause of early death is right ventricular failure.
In addition to anticoagulation therapy, several reperfusion therapies are being used to reverse right ventricular failure: systemic thrombolysis, surgical embolectomy, and catheter based therapy. Given the drawbacks of systemic thrombolytic therapy or surgical embolectomy, percutaneous catheter treatment is a reasonable alternative for patients with contraindications to systemic thrombolytic therapy or surgery. Current international consensus guidelines support the use of catheter interventions for selected pulmonary embolism patients at increased risk of adverse clinical outcomes.
The AngioJet Ultra PE Thrombectomy catheter introduces a pressurized high velocity saline stream through a catheter tip so that the clot within a blood vessel is trapped, broken into small pieces and aspirated from the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Experimental | Device: AngioJet Ultra PE Thrombectomy SystemPatients are treated with the AngioJet Ultra PE Thrombectomy System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomatic pulmonary embolism patients >18 years
- Availability of a baseline contrast-enhanced chest computed tomogram or conventional pulmonary angiogram with evidence of pulmonary embolus in at least one main or lobar pulmonary artery ≥ 6mm in diameter
- Availability of a baseline transthoracic echocardiogram with sufficient image quality permitting the measurement of right ventricular (RV) and left ventricular (LV) dimensions in the apical or subcostal four-chamber view
- Echocardiographic evidence of right ventricular dilatation with a subannular RV/LV ratio ≥ 0.9 from the apical or subcostal four-chamber view
- Appropriate informed consent was obtained from the patient or legal representative
Key exclusion criteria (5 listed)
- Patient has underwent Cardiopulmonary Resuscitation (CPR) in the last 48 hours
- Patient is participating in any other clinical study
- Pregnancy, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested or use a medically accepted method of birth control)
- Inability to comply with study Follow-up assessments (e.g. due to geographic)
- Previous enrollment in this study
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 |
|---|---|---|
| AngioJet Ultra PE Thrombectomy SystemAlso: AngioJetThrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System | Device | AngioJet Ultra PE Thrombectomy System |
Primary outcome
Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography
Time frame: Baseline to 24-48 hours
The change in the subannular end-diastolic RV/LV ratio at 24-48 hrs following thrombectomy compared to baseline measurements as assessed by an independent core lab analysis. RV and LV values will be measured by echocardiography, a technique utilizing ultrasound waves to assess heart activity.
10 secondary outcomes
Technical Success
Time frame: Index Procedure
Death - All Cause
Time frame: 3 months
Death - Cardiac Cause
Time frame: 3 months
Change in Systolic Pulmonary Arterial Blood Pressure
Time frame: Baseline to Post Index Procedure
Pulmonary Systolic Arterial Blood Pressure
Time frame: Post Index Procedure
Change in Systemic Systolic Arterial Blood Pressure
Time frame: Baseline to Post Index Procedure
Systemic Systolic Arterial Blood Pressure
Time frame: Post Index Procedure
Change in Heart Rate
Time frame: Baseline to Post Index Procedure
Vasopressor Support
Time frame: Index Procedure
Procedure Related Adverse Event Rate
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
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Inari VISION Registry
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RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
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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.
Nils Kucher, Prof Dr Med principal investigator
University of Bern
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AngioJet Ultra PE Thrombectomy System in people with Pulmonary Embolism, run by Boston Scientific Corporation at 7 sites in 4 countries.
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 5 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: stopped early, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, Germany, Portugal, Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography (time frame: Baseline to 24-48 hours). 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 5 Dec 2018.