Treatment of Low-Risk Submassive Pulmonary Embolism With FlowTriever
Not Applicable
Recruiting
- Conditions
- Pulmonary Embolism
- Interventions
- Device: FlowTriever
- Registration Number
- NCT05273762
- Lead Sponsor
- Northwell Health
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FlowTriever FlowTriever -
- Primary Outcome Measures
Name Time Method Change in mMRC dyspnea score from Baseline (state at time of admission to hospital) to 30-day follow-up.
- Secondary Outcome Measures
Name Time Method Change in Pulmonary Embolism Quality of Life Questionnaire (PEmbQOL) Procedure to 30-day, 3-month, and 6-month follow up. Hospital Duration Length of index hospitalization, length median of 9.1 days per AHA journal Echocardiogram Measurements: Change From pre-procedure echocardiogram compared to 30-day and compared to 6-month follow up 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 Oxygen Requirement Length of index hospitalization, length median of 9.1 days per AHA journal Bleeding Re-thrombosis Edema Pain From end of index hospitalization to 30 days post-procedure, whichever comes first 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. Change in hemodynamic measurements Before insertion of device during the procedure compared to 5 minutes after device is removed All-cause Mortality Length of index hospitalization, length median of 9.1 days per AHA journal Site Complications Length of index hospitalization, length median of 9.1 days per AHA journal 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 Time spent in the Intensive Care Unit (ICU) for the length of the hospital visit.
Trial Locations
- Locations (2)
Lenox Hill Hospital
🇺🇸New York, New York, United States
Northern Westchester Hospital
🇺🇸Mount Kisco, New York, United States