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NCT03761173 · ClinicalTrials.gov registry record
FlowTriever All-Comer Registry for Patient Safety and Hemodynamics
A clinical trial, sponsored by Inari Medical.
- Completed
- Registry status
- 1,200
- Enrollment target
NCT03761173: Completed study, sponsored by Inari Medical.
NCT03761173 is a clinical trial that has completed, run by Inari Medical. The registered enrollment target is 1,200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03761173 has completed, sponsored by Inari Medical.
- COMPLETED
- Registry status
- 1,200 participants
- Enrollment target
Study Summary
To 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 (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice. Up to 300 additional patients with anticoagulation treatment as the initial planned primary treatment strategy for intermediate risk PE will also be evaluated (US only).
Primary Outcome
MAEs are defined as a composite, when one or more of the following events occur: * Device-related mortality through 48 hours after the index procedure, or * Major bleeding through 48 hours after the index procedure, or * Intra-procedural device-related or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening, or * Device-related pulmonary vascular injury, or * Device-related cardiac injury The components of the composite MA
Interventions
- DEVICE FlowTriever System
- DRUG Anticoagulation Agents
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2018-12-15 |
| Est. Completion | 2024-09-04 |
What the finished NCT03761173 record still lists
NCT03761173 is an observational study that tracks outcomes without assigning an intervention. Its 1,200 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 2 interventions - of which FlowTriever System is the first listed.
NCT03761173 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03761173 about?
NCT03761173 is a clinical study titled "FlowTriever All-Comer Registry for Patient Safety and Hemodynamics". To 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 (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its...
What is the current status of trial NCT03761173?
This trial is currently completed. The enrollment target is 1,200 participants. The study started on 2018-12-15. Estimated completion is 2024-09-04.
What interventions are being tested in trial NCT03761173?
The interventions under investigation include: FlowTriever System (DEVICE), Anticoagulation Agents (DRUG).
Who is sponsoring clinical trial NCT03761173?
This trial is sponsored by Inari Medical, which has 12 total clinical trials registered on ClinicalTrials.gov.
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