Ignite Creation Date:
2024-05-06 @ 2:13 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01995500
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2013-11-14
Brief Title:
Angiography Study of BioNIR Drug Eluting Stent System NIREUS
Sponsor:
Medinol Ltd
Organization:
Medinol Ltd
Study Overview
Official Title:
BioNIR Ridaforolimus Eluting Coronary Stent System BioNIR EUropean Angiography Study
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIREUS
Brief 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
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 21 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None