Recruiting

FlowTriever

Sponsor:

Northwell Health

Code:

NCT05273762

Conditions

Pulmonary Embolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FlowTriever

Study Details

Brief summary:

This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.

Conditions

Pulmonary Embolism

Study ID

NCT05273762

Start date

Jan 25, 2022

Status verified date

Dec, 2023

Completion date

Jul 25, 2024

Anticipated

Primary completion date

Jul 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FlowTriever

Interventions

FlowTriever

Mechanical thrombectomy for pulmonary embolism

Primary outcome measure

  • Change in mMRC dyspnea score from [ Time Frame: Baseline (state at time of admission to hospital) to 30-day follow-up. ]

Central Contacts and Locations

Central contacts

Victoria Roselli, Clinical Research Coordinator

212-434-3695vroselli@northwell.edu

Locations

Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Contacts

Victoria Roselli

vroselli@northwell.edu

Principal Investigator:

Bushra Mina, MD

More Information

Sponsor

Northwell Health

Last update posted

Dec 28, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2023-12-28.