Ignite Creation Date:
2024-05-05 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00617084
Status:
COMPLETED
Last Update Posted:
2014-06-06
First Post:
2008-02-04
Brief Title:
Randomized Two-arm Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent
Sponsor:
Medtronic Vascular
Organization:
Medtronic Vascular
Study Overview
Official Title:
RESOLUTE-III All-comers Trial A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2014-05
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:
RESOLUTE-AC
Brief Summary:
The RESOLUTE-III Allcomers trial is a prospective multicenter randomized two-arm international non-inferiority open-label study with 2300 patients at 15-20 centers The study is a real world all comers study
Primary objective to compare the Medtronic Endeavor-Resolute Zotarolimus-Eluting stent system with the Abbott XIENCE V Everolimus-Eluting stent system with respect to cardiac death myocardial infarction not clearly attributable to a non-target vessel Target Lesion Revascularization at 1 year in a real world patient population
Primary objective to compare the Medtronic Endeavor-Resolute Zotarolimus-Eluting stent system with the Abbott XIENCE V Everolimus-Eluting stent system with respect to cardiac death myocardial infarction not clearly attributable to a non-target vessel Target Lesion Revascularization at 1 year in a real world patient population
Detailed Description:
The RESOLUTE-III Allcomers trial is a prospective multicenter randomized two-arm international non-inferiority open-label study with 2300 patients at 15-20 centers The study is a real world all comers study
Primary objective to compare the Medtronic Endeavor-Resolute Zotarolimus-Eluting stent system with the Abbott XIENCE V Everolimus-Eluting stent system with respect to cardiac death myocardial infarction not clearly attributable to a non-target vessel Target Lesion Revascularization at 1 year in a real world patient population
Study hypothesis To determine whether the Zotarolimus-Eluting stent Medtronic Endeavor-Resolute is non-inferior to the Everolimus-eluting stent Abbott XIENCE V in terms of the primary endpoint at 12 months after stent implantation
Primary objective to compare the Medtronic Endeavor-Resolute Zotarolimus-Eluting stent system with the Abbott XIENCE V Everolimus-Eluting stent system with respect to cardiac death myocardial infarction not clearly attributable to a non-target vessel Target Lesion Revascularization at 1 year in a real world patient population
Study hypothesis To determine whether the Zotarolimus-Eluting stent Medtronic Endeavor-Resolute is non-inferior to the Everolimus-eluting stent Abbott XIENCE V in terms of the primary endpoint at 12 months after stent implantation
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