Ignite Creation Date:
2024-05-06 @ 2:13 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01995487
Status:
COMPLETED
Last Update Posted:
2023-10-16
First Post:
2013-11-12
Brief Title:
Study of BioNIR Drug Eluting Stent System in Coronary Stenosis
Sponsor:
Medinol Ltd
Organization:
Medinol Ltd
Study Overview
Official Title:
BioNIR Ridaforolimus Eluting Coronary Stent System BioNIR In Coronary Stenosis Trial
Status:
COMPLETED
Status Verified Date:
2023-10
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:
BIONICS
Brief Summary:
The BioNIR study aims to show that the BioNIR ridaforolimus eluting stent is non-inferior to the Resolute zotarolimus-eluting stent for the primary clinical endpoint of target lesion failure TLF at 12 months that it is non-inferior to the Resolute for the secondary endpoint of angiographic in-stent late loss at 13 months and that it is more cost-effective
Detailed Description:
The BioNIR is a prospective multi-center single-blind two-arm randomized clinical trial The population will consist of subjects undergoing PCI for angina stable or unstable silent ischemia NSTEMI and recent STEMI Complex lesions are allowed There is no limit to the number of lesions per vessel or individual lesion length however the total planned stenting in the coronary tree cannot exceed 100mm
Randomization will be stratified by the presence of medically treated diabetes vs no medically treated diabetes acute coronary syndrome ACS vs non-ACS and by site Lesions planned to be treated must be declared and recorded at time of randomization Planned staged procedures if necessary must be declared immediately post procedure
Clinical follow-up will be performed at 30 days 6 months and 1 2 3 4 and 5 years post randomization 200 patients at participating North American sites will be consented for planned angiographic follow-up at 13 months after enrollment with 100 of these patients consented to undergo planned IVUS at baseline and at 13 months following randomization
The primary endpoint is Target Lesion Failure TLF at 12 months defined as the composite of cardiac death target vessel-related myocardial infarction or ischemia-driven target lesion revascularization
Clinical Secondary Endpoints to be evaluated at 30 days 6 months and 1 2 3 4 and 5 except as noted
Device Lesion and Procedure Success at time of baseline procedure
TLF at 30 days 6 months and 2 3 4 and 5 years defined as 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
All-cause mortality
Cardiac death
Myocardial Infarction
Target Vessel Related MI
Ischemia-driven TLR
Ischemia-driven TVR
Stent Thrombosis ARC definite and probable
Angiographic Sub-Study Secondary Endpoint to be evaluated at 13 months
Angiographic in-stent and in-segment late loss
IVUS Sub-Study Secondary Endpoint to be evaluated at 13 months
In-stent percent neointimal hyperplasia
Stent mal-apposition
A key component of this trial will be a prospective assessment of health care resource utilization costs and cost effectiveness A separate cost effectiveness assessment plan describes the data collection and analysis
Sample Size Consideration From recent US trials of best in class DES Xience V Promus Element and Resolute the 1-year TLF rate in patients with non-complex lesions not undergoing routine angiographic follow-up is approximately 38 Using the assumption of the more-comers design the 1-year event rate will be conservatively increased by 50 assuming enrollment rate for complex patientslesions is 50 with double the standard event rate - thus 58 Therefore with a one-sided 95 upper bound of the confidence interval of 33 a relative 57 margin and 11 randomization enrolling 1810 patients 905 per group provides 90 power to demonstrate non-inferiority Assuming 95 follow-up rate at 1 year approximately 1906 patients will be enrolled 953 in each group
Randomization will be stratified by the presence of medically treated diabetes vs no medically treated diabetes acute coronary syndrome ACS vs non-ACS and by site Lesions planned to be treated must be declared and recorded at time of randomization Planned staged procedures if necessary must be declared immediately post procedure
Clinical follow-up will be performed at 30 days 6 months and 1 2 3 4 and 5 years post randomization 200 patients at participating North American sites will be consented for planned angiographic follow-up at 13 months after enrollment with 100 of these patients consented to undergo planned IVUS at baseline and at 13 months following randomization
The primary endpoint is Target Lesion Failure TLF at 12 months defined as the composite of cardiac death target vessel-related myocardial infarction or ischemia-driven target lesion revascularization
Clinical Secondary Endpoints to be evaluated at 30 days 6 months and 1 2 3 4 and 5 except as noted
Device Lesion and Procedure Success at time of baseline procedure
TLF at 30 days 6 months and 2 3 4 and 5 years defined as 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
All-cause mortality
Cardiac death
Myocardial Infarction
Target Vessel Related MI
Ischemia-driven TLR
Ischemia-driven TVR
Stent Thrombosis ARC definite and probable
Angiographic Sub-Study Secondary Endpoint to be evaluated at 13 months
Angiographic in-stent and in-segment late loss
IVUS Sub-Study Secondary Endpoint to be evaluated at 13 months
In-stent percent neointimal hyperplasia
Stent mal-apposition
A key component of this trial will be a prospective assessment of health care resource utilization costs and cost effectiveness A separate cost effectiveness assessment plan describes the data collection and analysis
Sample Size Consideration From recent US trials of best in class DES Xience V Promus Element and Resolute the 1-year TLF rate in patients with non-complex lesions not undergoing routine angiographic follow-up is approximately 38 Using the assumption of the more-comers design the 1-year event rate will be conservatively increased by 50 assuming enrollment rate for complex patientslesions is 50 with double the standard event rate - thus 58 Therefore with a one-sided 95 upper bound of the confidence interval of 33 a relative 57 margin and 11 randomization enrolling 1810 patients 905 per group provides 90 power to demonstrate non-inferiority Assuming 95 follow-up rate at 1 year approximately 1906 patients will be enrolled 953 in each group
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