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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,350
The intervention is called Percutaneous Coronary Intervention (PCI); Commonly known as coronary angioplasty or simply angioplasty, it is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. PCI is usually performed by an interventional cardiologist.
The intervention is called Percutaneous Coronary Intervention (PCI); Commonly known as coronary angioplasty or simply angioplasty, it is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. PCI is usually performed by an interventional cardiologist.
MACE
The primary endpoint (MACE) is the composite of cardiac death, (Myocardial Infarction) MI and target lesion revascularization (TLR). These events will be collected post-procedure during the patient's hospitalization and at 6 , 12 and 24 month follow-up.
Time frame: 24 months
Medico economic evaluation
Data collection of acts and diagnosis specific codes related to any adverse event with hospitalization in relation with the endoprothesis allocated. It will be then analyzed by an dedicated expert who will be able to appreciate a cost/efficiency rate for each treatment arm.
Time frame: 24 months
Target Lesion Revascularization (TLR ) rate
Any study stent restenosis leading to a procedure or a surgery to treat it.
Time frame: 24 months
Stent thrombosis rate
Stent thrombosis will be evaluated as per the ARC classification (ie degree of evidence and time to event)
Time frame: 24 months
Success of the procedure
Defined as an efficient reintroduction of the blood flow in the target vessel post angioplasty. It's a "YES/NO" question.
Time frame: 24 months
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Clinique Claude Bernard
Albi, France
Clinique de l'Europe
Amiens, France
Hôpital Sud
Amiens, France
CHU Angers
Angers, France
CH Henri Duffaut
Avignon, France
Clinique La Fourcade
Bayonne, France
Polyclinique de Bois Bernard
Bois-Bernard, France
CHU Côte de Nacre
Caen, France
CH Cannes
Cannes, France
Centre hospitalier Louis Pasteur
Chartres, France
...and 32 more locations