Treatment of low-risk submassive pulmonary embolism using FlowTriever
Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever: Efficacy and Safety
This study is testing if the FlowTriever device can safely treat people with low-risk submassive pulmonary embolism who are stable and have certain health markers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 2 sites (Mount Kisco, New York and 1 other locations) |
| Trial ID | NCT05273762 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of the FlowTriever device for treating patients with low-risk submassive pulmonary embolism who are hemodynamically stable. Participants will be selected based on specific clinical criteria, including the presence of cardiac biomarkers or evidence of right ventricular strain. The treatment involves mechanical thrombectomy performed under conscious sedation. The goal is to assess how effectively this device can alleviate the condition while ensuring patient safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with low-risk submassive pulmonary embolism and specific clinical indicators of right ventricular strain.
Not a fit: Patients with active severe COVID-19 infection or those unable to receive anticoagulation will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for managing low-risk submassive pulmonary embolism, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using mechanical thrombectomy for pulmonary embolism, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Mount Kisco, New York and 1 other locations
- Northern Westchester Hospital — Mount Kisco, New York, United States (Enrolling_by_invitation)
- Lenox Hill Hospital — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Victoria Roselli, Clinical Research Coordinator
- Email: vroselli@northwell.edu
- Phone: 212-434-3695
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.