Ignite Creation Date:
2024-05-05 @ 9:07 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00819923
Status:
UNKNOWN
Last Update Posted:
2011-05-05
First Post:
2009-01-08
Brief Title:
Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome
Sponsor:
The Hospital District of Satakunta
Organization:
The Hospital District of Satakunta
Study Overview
Official Title:
Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome A Prospective Randomized and a Multicenter Clinical Study
Status:
UNKNOWN
Status Verified Date:
2011-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
BASE-ACS
Brief Summary:
The purpose of the trial is to compare the safety and effectiveness of bio-active-stent BAS and everolimus-eluting stent EES in patients presenting with acute coronary syndrome
Detailed Description:
The BASE-ACS trial is an academic study which will be conceived and conducted as a multicenter multi-country study by experienced interventional cardiologists This study is independent of commercial interests
The purpose of the trial is to compare the safety and effectiveness of bio-active-stent Titan-2 and everolimus-eluting stent Xience V Promus in patients presenting with acute coronary syndrome
A total of 850 patients will be included in the randomized study The primary end point MACE is the composite of cardiac death myocardial infarction and target lesion revascularization during 12 months of follow-up Enrollment of patients will start in November 2008 and end in 2009
The purpose of the trial is to compare the safety and effectiveness of bio-active-stent Titan-2 and everolimus-eluting stent Xience V Promus in patients presenting with acute coronary syndrome
A total of 850 patients will be included in the randomized study The primary end point MACE is the composite of cardiac death myocardial infarction and target lesion revascularization during 12 months of follow-up Enrollment of patients will start in November 2008 and end in 2009
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