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Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever

Primary Purpose

Pulmonary Embolism

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FlowTriever

About this trial

This is an interventional treatment trial for Pulmonary Embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

I1. ≥ 18 years of age

I2. Clinical signs and symptoms of low-risk submassive pulmonary embolism defined per 2019 ESC Guidelines:

At least one of the following:

Presence of either RV strain or RV dilation on CT scan
Troponin T > 0.01 ng/mL
Serum Pro-Brain Natriuretic Peptide (NT-proBNP) > 300 pg/mL
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.

I3. 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

I4. 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

Sites / Locations

Lenox Hill HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FlowTriever

Arm Description

Outcomes

Primary Outcome Measures

Change in mMRC dyspnea score from

Secondary Outcome Measures

Change in Pulmonary Embolism Quality of Life Questionnaire (PEmbQOL)

Change in Six Minute Walk Test (6MWT) (distance covered in meters over 6 minutes)

Echocardiogram Measurements: Change

ICU Length of Stay

Time spent in the Intensive Care Unit (ICU) for the length of the hospital visit.

Hospital Duration

Device related death Device related bleeding Device related vascular injury Device related cardiac injury Clinical deterioration Rescue intervention

Change in hemodynamic measurements

Site Complications

Oxygen Requirement

All-cause Mortality

Bleeding Re-thrombosis Edema Pain

Full Information

NCT ID

NCT05273762

First Posted

February 14, 2022

Last Updated

August 31, 2023

Sponsor

Northwell Health

Collaborators

Inari Medical

1. Study Identification

Unique Protocol Identification Number

NCT05273762

Brief Title

Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 25, 2022 (Actual)

Primary Completion Date

November 17, 2023 (Anticipated)

Study Completion Date

July 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwell Health

Collaborators

Inari Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Embolism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FlowTriever

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

FlowTriever

Intervention Description

Mechanical thrombectomy for pulmonary embolism

Primary Outcome Measure Information:

Title

Change in mMRC dyspnea score from

Time Frame

Baseline (state at time of admission to hospital) to 30-day follow-up.

Secondary Outcome Measure Information:

Title

Change in Pulmonary Embolism Quality of Life Questionnaire (PEmbQOL)

Time Frame

Procedure to 30-day, 3-month, and 6-month follow up.

Title

Change in Six Minute Walk Test (6MWT) (distance covered in meters over 6 minutes)

Time Frame

Pre-procedure to 30-day, 3-month, and 6-month follow up.

Title

Echocardiogram Measurements: Change

Time Frame

Pre-procedure to 30-day and 6-month follow up

Title

Echocardiogram Measurements: Change

Time Frame

From pre-procedure echocardiogram compared to 30-day and compared to 6-month follow up

Title

ICU Length of Stay

Description

Time spent in the Intensive Care Unit (ICU) for the length of the hospital visit.

Time Frame

Length of index hospitalization, length of hospitalization median of 9.1 days, length of ICU stay median 3.1 per JNS

Title

Hospital Duration

Time Frame

Length of index hospitalization, length median of 9.1 days per AHA journal

Title

Device related death Device related bleeding Device related vascular injury Device related cardiac injury Clinical deterioration Rescue intervention

Time Frame

From end of index hospitalization to 30 days post-procedure, whichever comes first

Title

Change in hemodynamic measurements

Time Frame

Before insertion of device during the procedure compared to 5 minutes after device is removed

Title

Site Complications

Time Frame

Length of index hospitalization, length median of 9.1 days per AHA journal

Title

Oxygen Requirement

Time Frame

Length of index hospitalization, length median of 9.1 days per AHA journal

Title

All-cause Mortality

Time Frame

Length of index hospitalization, length median of 9.1 days per AHA journal

Title

Bleeding Re-thrombosis Edema Pain

Time Frame

From end of index hospitalization to 30 days post-procedure, whichever comes first

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA I1. ≥ 18 years of age I2. Clinical signs and symptoms of low-risk submassive pulmonary embolism defined per 2019 ESC Guidelines: At least one of the following: Presence of either RV strain or RV dilation on CT scan Troponin T > 0.01 ng/mL Serum Pro-Brain Natriuretic Peptide (NT-proBNP) > 300 pg/mL 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. I3. 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 I4. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Victoria Roselli, Clinical Research Coordinator

Phone

212-434-3695

vroselli@northwell.edu

Facility Information:

Facility Name

Lenox Hill Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Individual Site Status

Recruiting

Facility Contact: