Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever

NCT05273762 | Unknown DMC FDA Device

• 1 other identifier: 21-1117
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change in mMRC dyspnea score from

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

Secondary Outcomes (12)

• 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

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

Study Arms (1)

FlowTriever

EXPERIMENTAL

Device: FlowTriever

Interventions

FlowTriever DEVICE

Mechanical thrombectomy for pulmonary embolism

FlowTriever

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• th 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Inari Medical: collaborator

Study Sites (2)

Northern Westchester Hospital

Mount Kisco, New York, 10549, United States

ENROLLING BY INVITATION

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Victoria Roselli, Clinical Research Coordinator

CONTACT

212-434-3695; vroselli@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 10, 2022
• Study Start: January 25, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 25, 2024
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

US (2)