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NIRTRAKS Post-Market Study (NIRTRAKS)

NCT02455804 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-10-04

Study results available
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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.

Conditions

  • de Novo Stenotic Lesions in Native Coronary Arteries

Interventions

DEVICE

Stenting procedure

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.

Sponsors & Collaborators

  • Medinol Ltd.

    lead INDUSTRY

Principal Investigators

  • Manesh R Patel, MD, FACC · Duke Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-08
Primary Completion
2020-01-14
Completion
2020-01-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02455804 on ClinicalTrials.gov