Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever
NCT ID: NCT05273762
Last Updated: 2023-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2022-01-25
2024-07-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FlowTriever
FlowTriever
Mechanical thrombectomy for pulmonary embolism
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FlowTriever
Mechanical thrombectomy for pulmonary embolism
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Inari Medical
INDUSTRY
Northwell Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northern Westchester Hospital
Mount Kisco, New York, United States
Lenox Hill Hospital
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Victoria Roselli, Clinical Research Coordinator
Role: CONTACT
Phone: 212-434-3695
Email: [email protected]
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Victoria Roselli
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21-1117
Identifier Type: -
Identifier Source: org_study_id