Treatment of low-risk submassive pulmonary embolism using FlowTriever

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Lenox Hill Hospital
  New York, New York, United States Recruiting
• Northern Westchester Hospital
  Mount Kisco, New York, United States Enrolling by invitation

Study contacts

• Study coordinator: Victoria Roselli, Clinical Research Coordinator
• Email: vroselli@northwell.edu
• Phone: 212-434-3695

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.