Frontlight ResearchEarly access
Taking people in United StatesNo phase
Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever
Key facts
- Who runs it
- Northwell Health
- Where
- Mount Kisco and New York, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 25 Jan 2022
- Expected to end
- 25 Jul 2027
- Type of study
- Interventional
- Treatments tested
- FlowTriever
- Record updated
- 1 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- I1. ≥ 18 years of age
- I2. Clinical signs and symptoms of low-risk Intermediate pulmonary embolism defined per 2019 ESC Guidelines:
- Only one of the following:
- Presence of either RV strain or RV dilation on CT scan or Echo TTE
- 4th generation Troponin T > 0.01 ng/mL or 5th generation Troponin T >14 ng/L; Troponin I > 51.4 ng/L (Northwell reference laboratory); I3. sPESI score 0 or >1*; *Signs of RV dysfunction on Echo TTE or CTPA or elevated cardiac biomarker levels may be present, despite a calculation of sPESI 0; I4. Echocardiogram, Computed Tomography Pulmonary Angiogram, or pulmonary angiographic evidence of proximal filing defect in at least one main, lobar, or segmental pulmonary artery with or without pulmonary infarction; I5. Hemodynamically stable
Who cannot take part
- E3. Known sensitivity to radiographic contrast agents that cannot be pre-treated
- E1. Patients with active and severe COVID-19 infection (e.g. using ventilator, requiring hemodynamic support)
- E2. Unable to anti-coagulate with heparin or alternative
- E4. Life expectancy < 6 months
- E5. Current participation in another study that may interfere with the patient's participation in this study
- E6. Inability to consent
- E7. Patient is pregnant or plans to become pregnant within the next 6 months and/or currently breastfeeding
- E8. Subsegmental pulmonary embolism only
Where in United States
- Northern Westchester HospitalMount Kisco, United StatesContact: Victoria Roselli, Clinical Research CoordinatorEnrolling by invitation
- Lenox Hill HospitalNew York, United StatesContact: Victoria RoselliTaking people
About the trial
What the trial wants to find out
This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.
The group in the trial
- FlowTrieverTreatment being tested
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever: Efficacy and Safety
- Record updated
- 1 October 2026