Clinical trial NCT05273762: 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
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Inari Medical
First posted: 2022-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in mMRC dyspnea score from
timeFrame: Baseline (state at time of admission to hospital) to 30-day follow-up.
Secondary outcomes:
measure: Change in Pulmonary Embolism Quality of Life Questionnaire (PEmbQOL)
timeFrame: Procedure to 30-day, 3-month, and 6-month follow up.
measure: Change in Six Minute Walk Test (6MWT) (distance covered in meters over 6 minutes)
timeFrame: Pre-procedure to 30-day, 3-month, and 6-month follow up.
measure: Echocardiogram Measurements: Change
timeFrame: Pre-procedure to 30-day and 6-month follow up
measure: Echocardiogram Measurements: Change
timeFrame: From pre-procedure echocardiogram compared to 30-day and compared to 6-month follow up
measure: ICU Length of Stay
timeFrame: Length of index hospitalization, length of hospitalization median of 9.1 days, length of ICU stay median 3.1 per JNS
measure: Hospital Duration
timeFrame: Length of index hospitalization, length median of 9.1 days per AHA journal
measure: Device related death Device related bleeding Device related vascular injury Device related cardiac injury Clinical deterioration Rescue intervention
timeFrame: From end of index hospitalization to 30 days post-procedure, whichever comes first
measure: Change in hemodynamic measurements
timeFrame: Before insertion of device during the procedure compared to 5 minutes after device is removed
measure: Site Complications
timeFrame: Length of index hospitalization, length median of 9.1 days per AHA journal
measure: Oxygen Requirement
timeFrame: Length of index hospitalization, length median of 9.1 days per AHA journal
measure: All-cause Mortality
timeFrame: Length of index hospitalization, length median of 9.1 days per AHA journal
measure: Bleeding Re-thrombosis Edema Pain
timeFrame: From end of index hospitalization to 30 days post-procedure, whichever comes first
Other outcomes:
Locations:
city: Mount Kisco
country: United States
facility: Northern Westchester Hospital
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
Study officials:
References: