NCT05273762 · Northwell Health
Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever
What this study is about
This study is focused on investigating the effectiveness and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.
View original scientific description
This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.
Interventions
DEVICE
FlowTriever
Mechanical thrombectomy for pulmonary embolism
Primary outcome measures
Change in mMRC dyspnea score from
Time frame: Baseline (state at time of admission to hospital) to 30-day follow-up.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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 E3. Known sensitivity to radiographic contrast agents that cannot be pre-treated 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
- Mount Kisco, New York
- New York, New York
Collaborators
Inari Medical
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2026 · Source of record for eligibility and locations