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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
New York
Northern Westchester Hospital
ENROLLING_BY_INVITATION
Mount Kisco
Lenox Hill Hospital
RECRUITING
New York
Contact Information
Primary
Victoria Roselli, Clinical Research Coordinator
vroselli@northwell.edu
212-434-3695
Time Frame
Start Date: 2022-01-25
Estimated Completion Date: 2024-07-25
Participants
Target number of participants: 30
Treatments
Experimental: FlowTriever
Related Therapeutic Areas
Sponsors
Leads: Northwell Health
Collaborators: Inari Medical

This content was sourced from clinicaltrials.gov

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