Status:
UNKNOWN
Comparative Phase IV Study: Efficacy And Safety of TiTAN2 Versus COBALT-CHROME Stents- EVIDENCEII
Lead Sponsor:
Hexacath, France
Conditions:
Silent Myocardial Infarction
Stable Angina
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 th...
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 re...
Eligibility Criteria
Inclusion
- Patient with symptomatic de novo coronary lesion involving one or two vessels
- Patient presenting a lesion with \> 50% stenosis
- Patient who must undergo a percutaneous coronary intervention (PCI) in the indications of Cobalt-chromium bare metal stents and TITAN2 stents and being able to be indifferently treated with one or the other of these stents.
- Written informed consent
- Expected survival \> 2 years
- Patient reachable by phone throughout the duration of the study.
Exclusion
- Pregnant/Lactating women
- Women of childbearing potential (last menstrual period \<12 months) not using effective contraception
- Patient under legal protection
- Indication of coronary artery bypass graft surgery (CABG)
- History of coronary artery bypass graft surgery (CABG)
- Intrastent restenosis lesion
- Bifurcation lesion with the exception of those treated with a standardized approach (provisional stenting with final kissing in the side branch)
- Left main coronary lesion
- Ostial target lesion
- Previous drug-eluting stenting
- Previous bare metal stenting or balloon angioplasty in the 12 months prior the inclusion; if this implantation involved the target artery, separate the new implanted stent at a distance ≥ 10 mm.
- History of stent thrombosis
- Heavily calcified lesion
- Use of the Rotablator
- Left ventricular ejection fraction (LVEF) \< 30%
- Cardiac arrest, cardiogenic shock or severe heart failure (Killip stage III or IV)
- Severe chronic renal failure (creatinine clearance \<30 ml min)
- Cardiac or renal transplantation
- Major surgery within the last 14 days
- Surgery scheduled within 30 days (non-ACS patients) or 12 months (if ACS) at the time of the randomization
- History of major bleeding
- Pathology with major risk of bleeding or any condition, allergy or intolerance which is incompatible with anticoagulation and / or extended antiplatelet therapy
- Known allergy to Titanium, Nickel, Cobalt or Chromium
- Patient currently participating in another clinical trial
- Non-compliant patient (treatment and follow-up)
- Patient living abroad
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
1350 Patients enrolled
Trial Details
Trial ID
NCT01918150
Start Date
March 1 2011
End Date
March 1 2016
Last Update
January 8 2014
Active Locations (42)
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1
Clinique Claude Bernard
Albi, France
2
Clinique de l'Europe
Amiens, France
3
Hôpital Sud
Amiens, France
4
CHU Angers
Angers, France