Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-26 @ 11:57 PM
Study NCT ID:
NCT01918150
Status:
UNKNOWN
Last Update Posted:
2014-01-08
First Post:
2013-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Phase IV Study: Efficacy And Safety of TiTAN2 Versus COBALT-CHROME Stents- EVIDENCEII
Sponsor:
Hexacath, France
Organization:
Study Overview
Official Title:
A French, Multicentric, Randomized, Simple Blind, Superiority Study Comparing the Efficiency and the Safety at 24 Months of the Stent Titan2 Versus Bare Metal Stent in Cobalt-Chrome in All Comers Patients Among Which 40 % Present an ACS.
Status:
UNKNOWN
Status Verified Date:
2014-01
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:
EVIDENCE II
Brief Summary:
The purpose of this study is to compare the effectiveness and safety, at 24 months, of the TITAN2 stent to any bare-metal stent (BMS) in Cobalt-Chromium in a population presenting an indication for these stents among 40% of which present an acute coronary syndrome (ACS).
Detailed Description:
The EVIDENCE II trial is a post-registration study for TITAN2 stent initiated on the request of the French Health Authorities' (HAS) in June 2009 for the next renewal of registration on the list of reimbursable products and services in France.
The study is so designed to compare the effectiveness and safety at 24 months of the TiTAN2 versus Cobalt-Chromium BMS randomly assigned. As a part of the secondary objectives, a cost-effectiveness study is also planned.
The comparators are cobalt chromium stents CE marketed and free of any coating (nude BMS).
All will be used in their authorized indications.
A total of 1350 patients will be included over a period of a year or more and followed for 24 months for the primary endpoint (MACE rate at 24 months in the overall population : cumulative incidence of cardiac deaths, MI and target lesion revascularization (TLR)).
Patients will also be clinically followed at 6 and 12 months . Medico economic datas are to collect at a similar time point.
An independent Clinical Event Committee, unaware of the treatment allocation, will be in charge of the adjudication of all the cardiac events including MACE (main objective)collected.
The calculation of the number of subjects specifies that 1350 patients are needed to meet the primary endpoint of the study.
Enrolled patient will be randomly assigned in a 2:1 fashion as follows :
* 900 patients in TITAN2 arm including 360 with ACS (Arm A)
* 450 patients in Cobalt-chromium arm including 180 with ACS (Arm B) In case of more than one stent needed, the protocol mandated using the same stent than the one assigned in all the lesions treated.
The study is so designed to compare the effectiveness and safety at 24 months of the TiTAN2 versus Cobalt-Chromium BMS randomly assigned. As a part of the secondary objectives, a cost-effectiveness study is also planned.
The comparators are cobalt chromium stents CE marketed and free of any coating (nude BMS).
All will be used in their authorized indications.
A total of 1350 patients will be included over a period of a year or more and followed for 24 months for the primary endpoint (MACE rate at 24 months in the overall population : cumulative incidence of cardiac deaths, MI and target lesion revascularization (TLR)).
Patients will also be clinically followed at 6 and 12 months . Medico economic datas are to collect at a similar time point.
An independent Clinical Event Committee, unaware of the treatment allocation, will be in charge of the adjudication of all the cardiac events including MACE (main objective)collected.
The calculation of the number of subjects specifies that 1350 patients are needed to meet the primary endpoint of the study.
Enrolled patient will be randomly assigned in a 2:1 fashion as follows :
* 900 patients in TITAN2 arm including 360 with ACS (Arm A)
* 450 patients in Cobalt-chromium arm including 180 with ACS (Arm B) In case of more than one stent needed, the protocol mandated using the same stent than the one assigned in all the lesions treated.
Study Oversight
Has Oversight DMC:
True
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?: