Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05273762
• Other study ID #: 21-1117
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: July 25, 2024

Study information

• Verified date: December 2023
• Source: Northwell Health
• Contact: Victoria Roselli, Clinical Research Coordinator
• Phone: 212-434-3695
• Email: vroselli[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 25, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• FlowTriever
Mechanical thrombectomy for pulmonary embolism

Locations

Country	Name	City	State
United States	Northern Westchester Hospital	Mount Kisco	New York
United States	Lenox Hill Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Inari Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mMRC dyspnea score from		Baseline (state at time of admission to hospital) to 30-day follow-up.
Secondary	Change in Pulmonary Embolism Quality of Life Questionnaire (PEmbQOL)		Procedure to 30-day, 3-month, and 6-month follow up.
Secondary	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.
Secondary	Echocardiogram Measurements: Change		Pre-procedure to 30-day and 6-month follow up
Secondary	Echocardiogram Measurements: Change		From pre-procedure echocardiogram compared to 30-day and compared to 6-month follow up
Secondary	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
Secondary	Hospital Duration		Length of index hospitalization, length median of 9.1 days per AHA journal
Secondary	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
Secondary	Change in hemodynamic measurements		Before insertion of device during the procedure compared to 5 minutes after device is removed
Secondary	Site Complications		Length of index hospitalization, length median of 9.1 days per AHA journal
Secondary	Oxygen Requirement		Length of index hospitalization, length median of 9.1 days per AHA journal
Secondary	All-cause Mortality		Length of index hospitalization, length median of 9.1 days per AHA journal
Secondary	Bleeding Re-thrombosis Edema Pain		From end of index hospitalization to 30 days post-procedure, whichever comes first