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NCT02381509 · ClinicalTrials.gov registry record
Predicting the Safety and Effectiveness of Inferior Vena Cava Filters
A clinical trial, sponsored by Carelon Research.
- Completed
- Registry status
- 1,428
- Enrollment target
NCT02381509: Completed study, sponsored by Carelon Research.
NCT02381509 is a clinical trial that has completed, run by Carelon Research. The registered enrollment target is 1,428 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02381509 has completed, sponsored by Carelon Research.
- COMPLETED
- Registry status
- 1,428 participants
- Enrollment target
Study Summary
PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 6 manufacturers placed in subjects for the prevention of pulmonary embolism (PE). This study will enroll up to 1,800 IVC filter subjects (with a maximum of 300 subjects per IVC filter brand) at up to 60 sites in the US. The primary objective of this investigational device exemption (IDE) clinical investigation is to evaluate the safety and effectiveness of the commercially available IVC filters (retrievable and permanent) in subjects with clinical need for mechanical prophylaxis of PE with an IVC filter.
Primary Outcome
Clinically significant perforation is defined as protrusion of filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ or that triggers the decision to remove the filter; resulting in an attempt to remove the IVC filter or requiring other intervention. Filter embolization is defined as movement of the filter or its components to a distant anatomic site completely out of the target zone after successful filter placement, confirm
Interventions
- DEVICE IVC Filter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,428 participants |
| Start Date | 2015-10 |
| Est. Completion | 2021-09-20 |
What the finished NCT02381509 record still lists
NCT02381509 is an observational study that tracks outcomes without assigning an intervention. Its 1,428 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which IVC Filter is the first listed.
NCT02381509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02381509 about?
NCT02381509 is a clinical study titled "Predicting the Safety and Effectiveness of Inferior Vena Cava Filters". PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 6 manufacturers placed in subjects for the prevention of pulmonary embolism (PE). This study will enroll up to 1,800 IVC filter subjects (with a maximum of 300 subjects per IV...
What is the current status of trial NCT02381509?
This trial is currently completed. The enrollment target is 1,428 participants. The study started on 2015-10. Estimated completion is 2021-09-20.
What interventions are being tested in trial NCT02381509?
The interventions under investigation include: IVC Filter (DEVICE).
Who is sponsoring clinical trial NCT02381509?
This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.
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