FlowTriever for Acute Massive Pulmonary Embolism (FLAME)
United States115 participantsStarted 2021-03-16
Plain-language summary
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Age \>=18 years Treatment team determines pulmonary embolism is the cause of shock, and the PE is high-risk per the protocol definitions
Exclusion Criteria:
* Out of hospital cardiac arrest with Glasgow Coma Scale of ≤8
* Witnessed cardiac arrest with ongoing CPR \>30 minutes
* Contraindication to anticoagulants, i.e. heparin or alternative
* Hematocrit \<28%
* Platelets \<25,000/μL
* INR \>8
* Intracardiac thrombus and/or intracardiac clot in transit
* Known anaphylactic sensitivity to radiographic agents that cannot be pre-treated
* History of pulmonary hypertension with systolic pulmonary arterial pressure \>70 mmHg
* Presence of chronic medical conditions with estimated \< 90 days life expectancy per physician discretion (should not consider the current pulmonary embolism and its treatment)
* Current participation in another drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
* Patient is known to be COVID-19 positive at hospital admission (patient has active COVID-19)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding
Timeframe: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.