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NCT04795167 · ClinicalTrials.gov registry record
FlowTriever for Acute Massive Pulmonary Embolism (FLAME)
A clinical trial, sponsored by Inari Medical.
- Completed
- Registry status
- 115
- Enrollment target
NCT04795167: Completed study, sponsored by Inari Medical.
NCT04795167 is a clinical trial that has completed, run by Inari Medical. The registered enrollment target is 115 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04795167 has completed, sponsored by Inari Medical.
- COMPLETED
- Registry status
- 115 participants
- Enrollment target
Study Summary
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism
Primary Outcome
The primary endpoint is the in-hospital composite endpoint of all-cause mortality, bailout to an alternative thrombus removal strategy, clinical deterioration, and major bleeding (BARC 3b/3c/5a/5b definition). The primary endpoint was assessed in the FlowTriever Arm compared to a pre-specified performance goal of 32%. Subjects in the Context Arm were analyzed separately using descriptive methods. The primary endpoint in the Context Arm was not compared to a performance goal. Data collection for
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2021-03-16 |
| Est. Completion | 2022-12-19 |
What the finished NCT04795167 record still lists
NCT04795167 is an observational study that tracks outcomes without assigning an intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04795167 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04795167 about?
NCT04795167 is a clinical study titled "FlowTriever for Acute Massive Pulmonary Embolism (FLAME)". To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism
What is the current status of trial NCT04795167?
This trial is currently completed. The enrollment target is 115 participants. The study started on 2021-03-16. Estimated completion is 2022-12-19.
Who is sponsoring clinical trial NCT04795167?
This trial is sponsored by Inari Medical, which has 12 total clinical trials registered on ClinicalTrials.gov.
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