NCT01995500

Angiography Study of BioNIR Drug Eluting Stent System (NIREUS)

BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) EUropean Angiography Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Medinol Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The NIREUS study aims to demonstrate angiographic non-inferiority for the BioNIR Ridaforolimus Eluting Coronary Stent System (hereafter referred to as BioNIR) in comparison to the Resolute zotarolimus-eluting stent (hereafter referred to as Resolute). The trial hypothesis is that the BioNIR is non-inferior to the Resolute for the primary endpoint of angiographic in-stent late loss at 6 months.

Detailed description

This is a prospective, multi-center, single-blind, two-arm, 2:1 randomized clinical trial. Randomization will be stratified by the presence of medically treated diabetes vs. no medically treated diabetes and by site. Lesions planned to be treated must be declared and recorded at time of randomization. Angiographic follow-up will be performed at 6 months. Clinical follow-up will be performed at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post randomization. The Primary Endpoint is in-stent late loss at 6 months as measured by the angiographic core laboratory. Angiographic Secondary Endpoints to be evaluated at 6 months are: * In-segment late loss * Follow-up percent diameter stenosis (in-stent and in-segment) * Binary restenosis (in-stent and in-segment) * Length and patterns of angiographic restenosis (Mehran classification) Clinical Secondary Endpoints to be evaluated at 30 days, 6 months, and 1, 2, 3, 4 and 5 years, except as noted, are: * Device, Lesion, and Procedure Success at time of baseline procedure * Target lesion failure (TLF; the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR) * Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR) * Target vessel failure (TVF; the composite rate of death, target vessel-related MI, or ischemia-driven TVR) * Overall Mortality * Cardiac Death * Myocardial Infarction * Target Vessel Related MI * Ischemia-driven TLR * Ischemia-driven TVR * Stent Thrombosis (ARC definite and probable)

Conditions

• Coronary Artery Stenosis

Interventions

Type	Name	Description
DEVICE	BioNIR	drug-eluting stent
DEVICE	Resolute	drug-eluting stent

Timeline

• Start date: 2014-03-19
• Primary completion: 2015-03-19
• Completion: 2020-06-17
• First posted: 2013-11-26
• Last updated: 2021-02-21

Locations

1 site across 1 country: Israel