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NCT02455804 · ClinicalTrials.gov registry record · NA
NIRTRAKS Post-Market Study (NIRTRAKS)
A NA study, sponsored by Medinol.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
NCT02455804: Completed NA study, sponsored by Medinol.
NCT02455804 is a NA study that has completed, run by Medinol. The registered enrollment target is 65 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02455804, a NA study, has completed, sponsored by Medinol.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
Study Summary
This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.
Primary Outcome
The primary endpoint in this study was TVF (Target Vessel Failure) defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 3 years post-procedure.
Interventions
- DEVICE Stenting procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2016-01-08 |
| Est. Completion | 2020-01-14 |
| Phase | NA |
What the finished NCT02455804 record still lists
NCT02455804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Stenting procedure is the first listed.
NCT02455804 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02455804 about?
NCT02455804 is a clinical study titled "NIRTRAKS Post-Market Study (NIRTRAKS)". This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US). All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting pr...
What is the current status of trial NCT02455804?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2016-01-08. Estimated completion is 2020-01-14.
What interventions are being tested in trial NCT02455804?
The interventions under investigation include: Stenting procedure (DEVICE).
Who is sponsoring clinical trial NCT02455804?
This trial is sponsored by Medinol, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02455804's enrollment target sits among peer trials
65 1144th of 2000 higher than 854 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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