CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 65 enrolled
Drug / intervention
Stenting proceduredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02455804
NCT02455804N/ACompleted
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NIRTRAKS - (NIRxcell TRial for a Post mArKet Study)

Medinol Ltd.·interventional·Posted May 28, 2015·Updated Oct 4, 2023

In Brief

A clinical study evaluating Stenting procedure for de Novo Stenotic Lesions in Native Coronary Arteries. Completed, enrolled 65 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Conditionsde Novo Stenotic Lesions in Native Coronary Arteries
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 28, 2015
Enrollment StartJan 8, 2016
Primary CompletionJan 14, 2020
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 11.1 years ago

Interventions

Stenting proceduredevice

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.