Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever

Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever: Efficacy and Safety

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

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: FlowTriever

Detailed Description

In this study, patients that present with low-risk submassive pulmonary embolism with hemodynamic stability and with either positivity of cardiac biomarkers, or radiographic or echocardiographic evidence of right ventricular strain will be assigned to be treated with mechanical thrombectomy, which includes conscious sedation, via FlowTriever.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• United States
  • New York
    • Mount Kisco, New York, United States, 10549
      • Enrolling by invitation
      • Northern Westchester Hospital
    • New York, New York, United States, 10075
      • Recruiting
      • Lenox Hill Hospital
      • Sub-Investigator: Jonathan Moore, MD
      • Sub-Investigator: Craig Basman, MD
      • Principal Investigator: Bushra Mina, MD
      • Sub-Investigator: Chad Kliger, MD
      • Sub-Investigator: Biana Trost, MD
      • Sub-Investigator: Arber Kodra, MD
      • Sub-Investigator: Miguel Alvarez Villela, MD
      • Sub-Investigator: Zein Kattih, MD
      • Contact: Victoria Roselli; Email: vroselli@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FlowTriever	Device: FlowTriever; Mechanical thrombectomy for pulmonary embolism

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pulmonary Embolism Quality of Life Questionnaire (PEmbQOL)		Procedure to 30-day, 3-month, and 6-month follow up.
Change in Six Minute Walk Test (6MWT) (distance covered in meters over 6 minutes)		Pre-procedure to 30-day, 3-month, and 6-month follow up.
Echocardiogram Measurements: Change		Pre-procedure to 30-day and 6-month follow up
Echocardiogram Measurements: Change		From pre-procedure echocardiogram compared to 30-day and compared to 6-month follow up
ICU Length of Stay	Time spent in the Intensive Care Unit (ICU) for the length of the hospital visit.	Length of index hospitalization, length of hospitalization median of 9.1 days, length of ICU stay median 3.1 per JNS
Hospital Duration		Length of index hospitalization, length median of 9.1 days per AHA journal
Device related death Device related bleeding Device related vascular injury Device related cardiac injury Clinical deterioration Rescue intervention		From end of index hospitalization to 30 days post-procedure, whichever comes first
Change in hemodynamic measurements		Before insertion of device during the procedure compared to 5 minutes after device is removed
Site Complications		Length of index hospitalization, length median of 9.1 days per AHA journal
Oxygen Requirement		Length of index hospitalization, length median of 9.1 days per AHA journal
All-cause Mortality		Length of index hospitalization, length median of 9.1 days per AHA journal
Bleeding Re-thrombosis Edema Pain		From end of index hospitalization to 30 days post-procedure, whichever comes first

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Inari Medical

Publications and helpful links

Helpful Links

• Predictors of 30-day hospital readmission after mechanical thrombectomy

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 25, 2024

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: 21-1117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes