NCT05273762 Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever
| NCT ID | NCT05273762 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwell Health |
| Condition | Pulmonary Embolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-01-25 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2022-01-25 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05273762 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Embolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05273762 currently recruiting?
Yes, NCT05273762 is actively recruiting participants. Contact the research team at vroselli@northwell.edu for enrollment information.
Where is the NCT05273762 trial being conducted?
This trial is being conducted at Mount Kisco, United States, New York, United States.
Who is sponsoring the NCT05273762 clinical trial?
NCT05273762 is sponsored by Northwell Health. The trial plans to enroll 30 participants.