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NCT02394912 · ClinicalTrials.gov registry record · NA
Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI™ With Crux® VCF System
A NA study, sponsored by Volcano Corporation.
- Terminated
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT02394912: Clinical Trial NA study, sponsored by Volcano Corporation.
NCT02394912 is a NA study that was terminated before completion, run by Volcano Corporation. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02394912, a NA study, was terminated before completion, sponsored by Volcano Corporation.
- TERMINATED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of the LUMIFI with Crux VCF System for deployment of the Crux VCF. The study will compare the method of Crux VCF deployment using the LUMIFI with Crux VCF System (IVUS guidance) with the historical results of the Crux VCF System (fluoroscopic guidance). The study will include enrollment into a roll in phase consisting of 2 study subjects per site prior to enrollment into the primary treatment phase for primary analyses. The purpose of the roll in phase is to assure compliance with site training on the use of the investigational device and protocol workflow.
Primary Outcome
All Subjects, Cohort A and Cohort B were included in the safety analysis. The primary endpoint of effectiveness, defined as technical success included only subjects within Cohort B. Technical success of filter placement is defined as the primary deployment of the filter such that the investigator judges the location to be suitable to provide sufficient mechanical protection against pulmonary embolism. Due to early stoppage of the study, enrollment of 100 subjects required to test the null hypot
Interventions
- DEVICE vena cava filter implantation (LUMIFI with Crux VCF System)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-11-09 |
| Phase | NA |
Why NCT02394912 stopped before completion
NCT02394912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which vena cava filter implantation (LUMIFI with Crux VCF System) is the first listed.
NCT02394912 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02394912 about?
NCT02394912 is a clinical study titled "Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI™ With Crux® VCF System". The purpose of this study is to evaluate the safety and effectiveness of the LUMIFI with Crux VCF System for deployment of the Crux VCF. The study will compare the method of Crux VCF deployment using the LUMIFI with Crux VCF System (IVUS guidance) with the historical results of the Crux VCF System (...
What is the current status of trial NCT02394912?
This trial is currently terminated. It is a NA study. The enrollment target is 21 participants. The study started on 2015-06. Estimated completion is 2016-11-09.
What interventions are being tested in trial NCT02394912?
The interventions under investigation include: vena cava filter implantation (LUMIFI with Crux VCF System) (DEVICE).
Who is sponsoring clinical trial NCT02394912?
This trial is sponsored by Volcano Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02394912's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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