FlowTriever Pulmonary Embolectomy Clinical Study
Part of paid clinical trials in Auburn, Alabama.
- Sponsor
- Inari Medical
- Study ID
- NCT02692586
- Status
- Completed
Conditions
- Acute Pulmonary Embolism
- Massive Pulmonary Embolism
- Pulmonary Embolism
- Submassive Pulmonary Embolism
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- FlowTriever System — DEVICE
Study Details
Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism.
Key Dates
- First listed
- Feb 26, 2016
- Start date
- Apr 30, 2016
- Status verified
- Apr 2021
- Primary completion
- Nov 30, 2017
- Completion
- Nov 30, 2017
Study Design
- Enrollment
- 106 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: FlowTriever System
Primary Outcome Measure
Change in RV/LV Ratio [ Time Frame: Baseline to 48 hours ]
Locations (18)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| East Alabama Heart & Vascular | Auburn | Alabama | - | - |
| St. Vincent's | Birmingham | Alabama | - | - |
| Cedars-Sinai Medical Center | Los Angeles | California | - | - |
| Florida Hospital | Orlando | Florida | - | - |
| Sacred Heart Hospital | Pensacola | Florida | - | - |
| Tampa General Hospital | Tampa | Florida | - | - |
| Emory University | Atlanta | Georgia | - | - |
| Ephraim McDowell Regional Medical Center | Danville | Kentucky | - | - |
| Baptist Health | Louisville | Kentucky | - | - |
| East Jefferson General Hospital | Metairie | Louisiana | - | - |
| North Shore University Hospital | Manhasset | New York | - | - |
| Ohio State University | Columbus | Ohio | - | - |
| OhioHealth Riverside Methodist Hospital | Columbus | Ohio | - | - |
| UPMC Hamot | Erie | Pennsylvania | - | - |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | - | - |
| UPMC | Pittsburgh | Pennsylvania | - | - |
| Houston Methodist Hospital | Houston | Texas | - | - |
| Charleston Area Medical Center | Charleston | West Virginia | - | - |
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