Pulmonary EmbolismFLARENCT02692586
FlowTriever Pulmonary Embolectomy Clinical Study
A study testing FlowTriever System in people with Pulmonary Embolism and Acute Pulmonary Embolism, run by Inari Medical at 18 sites in United States.
Trial summary
Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Embolism, Acute Pulmonary Embolism, Submassive Pulmonary Embolism
- What is being tested?
- FlowTriever System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 18 sitesUnited States
- Study dates
- Apr 2016to Nov 2017
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical signs, symptoms and presentation consistent with acute PE
- PE symptom duration ≤ 14 days
- CTA evidence of proximal PE
- RV/LV ratio ≥ 0.9 without syncope
- Systolic BP ≥ 90 mmHg
- Stable heart rate <130 BPM prior to procedure
- Patient deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment
Who cannot join
- Thrombolytic use within 30 days of baseline CTA
- Pulmonary hypertension with peak PAP > 70 mmHg by right heart catheterization
- Vasopressor requirement after fluids to keep pressure ≥ 90 mm Hg
- FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
- Hematocrit < 28% within 6 hours of index procedure
- Platelets < 100,000/µL
Show all 26Show fewer
- Serum creatinine > 1.8 mg/dL
- INR > 3
- Major trauma ISS > 15
- Presence of intracardiac lead in right ventricle or atrium placed within 6 months
- Cardiovascular or pulmonary surgery within last 7 days
- Actively progressing cancer
- Known bleeding diathesis or coagulation disorder
- Left bundle branch block
- History of severe or chronic pulmonary arterial hypertension
- History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
- History of uncompensated heart failure
- History of underlying lung disease that is oxygen-dependent
- History of chest irradiation
- History of Heparin-induced thrombocytopenia
- Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
- Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- Imaging evidence or other evidence that suggests the subject is not appropriate for mechanical thrombectomy intervention
- Life expectancy of < 90 days
- Female who is pregnant or nursing
- Current participation in another investigational drug or device treatment study
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Emory University
Atlanta, Georgia
East Alabama Heart & Vascular
Auburn, Alabama
St. Vincent's
Birmingham, Alabama
Charleston Area Medical Center
Charleston, West Virginia
Ohio State University
Columbus, Ohio
OhioHealth Riverside Methodist Hospital
Columbus, Ohio
Ephraim McDowell Regional Medical Center
Danville, Kentucky
UPMC Hamot
Erie, Pennsylvania
Houston Methodist Hospital
Houston, Texas
Cedars-Sinai Medical Center
Los Angeles, California
Baptist Health
Louisville, Kentucky
North Shore University Hospital
Manhasset, New York
East Jefferson General Hospital
Metairie, Louisiana
Florida Hospital
Orlando, Florida
Sacred Heart Hospital
Pensacola, Florida
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania
UPMC
Pittsburgh, Pennsylvania
Tampa General Hospital
Tampa, Florida
About this study
Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism.
- Conditions
- Pulmonary Embolism, Acute Pulmonary Embolism, Submassive Pulmonary Embolism, Massive Pulmonary Embolism
- Being tested
- FlowTriever System
- Keywords
- Thromboembolism, Thrombectomy, Right Heart Strain, Submassive PE, Right Ventricle Dysfunction, Massive PE
- Medical subject headings
- Pulmonary Embolism, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowTriever SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| FlowTriever System | Experimental | Not described Receives: Device: FlowTriever System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in RV/LV Ratio
Change in RV/LV ratio from baseline to 48 hours
Measured: Baseline to 48 hours
Number of Participants With Major Adverse Events
Device-related death, major bleeding, and treatment related AEs
Measured: Within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2017
- Study completionNov 2017
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.
- 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inari Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Rosenfield, MD, Study chair, Massachusetts General HospitalVictor Tapson, MD, Study chair, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692586
- Sponsor's protocol ID
- 15-001
- Acronym
- FLARE
- Status last verified
- Apr 2021
- First submitted
- 23 Feb 2016
- Last updated
- 24 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FlowTriever Pulmonary Embolectomy Clinical Study
- ClinicalTrials.gov ID
- NCT02692586
- Acronym / sponsor ID
- FLARE / 15-001
- Conditions
- Pulmonary Embolism, Acute Pulmonary Embolism, Submassive Pulmonary Embolism, Massive Pulmonary Embolism
- Keywords
- Thromboembolism, Thrombectomy, Right Heart Strain, Submassive PE, Right Ventricle Dysfunction, Massive PE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Inari MedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Posted 29 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FlowTriever System | Experimental | Device: FlowTriever System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical signs, symptoms and presentation consistent with acute PE
- PE symptom duration ≤ 14 days
- CTA evidence of proximal PE
- RV/LV ratio ≥ 0.9 without syncope
- Systolic BP ≥ 90 mmHg
Key exclusion criteria (26 listed)
- Thrombolytic use within 30 days of baseline CTA
- Pulmonary hypertension with peak PAP > 70 mmHg by right heart catheterization
- Vasopressor requirement after fluids to keep pressure ≥ 90 mm Hg
- FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
- Hematocrit < 28% within 6 hours of index procedure
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 |
|---|---|---|
| FlowTriever System | Device | FlowTriever System |
Primary outcome
Change in RV/LV Ratio
Time frame: Baseline to 48 hours
Change in RV/LV ratio from baseline to 48 hours
Number of Participants With Major Adverse Events
Time frame: Within 48 hours
Device-related death, major bleeding, and treatment related AEs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Kenneth Rosenfield, MD study chair
Massachusetts General Hospital
Victor Tapson, MD study chair
Cedars-Sinai Medical Center
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlowTriever System in people with Pulmonary Embolism and Acute Pulmonary Embolism, run by Inari Medical at 18 sites in United States.
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 7 inclusion and 26 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: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2021). 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 RV/LV Ratio (time frame: Baseline to 48 hours). The study lists 2 primary outcomes in all. 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 May 2021.