NCT02455804

NIRTRAKS Post-Market Study (NIRTRAKS)

NIRTRAKS - (NIRxcell TRial for a Post mArKet Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Medinol Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The main objective of this study is to collect and analyze additional information about the safety and effectiveness of the NIRxcell Stent System in the treatment of de novo stenotic lesions in native coronary arteries in the US population. The primary endpoint will be the rate of target vessel failure (TVF) at 3 years of treatment with the NIRxcell Stent System. This rate will be compared with a performance goal derived from a meta-analysis of coronary stenting with bare metal stents (BMS).

Conditions

• de Novo Stenotic Lesions in Native Coronary Arteries

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-08
• Primary completion: 2020-01-14
• Completion: 2020-01-14
• First posted: 2015-05-28
• Last updated: 2023-10-04
• Results posted: 2023-10-04

Locations

1 site across 1 country: United States