Comparative Phase IV Study: Efficacy And Safety of TiTAN2 Versus COBALT-CHROME Stents- EVIDENCEII
EVIDENCE II
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.
1 other identifier
interventional
1,350
1 country
42
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2011
Longer than P75 for phase_4
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 2, 2013
CompletedFirst Posted
Study publicly available on registry
August 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJanuary 8, 2014
January 1, 2014
4.8 years
August 2, 2013
January 7, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
24 months
Secondary Outcomes (4)
Medico economic evaluation
24 months
Target Lesion Revascularization (TLR ) rate
24 months
Stent thrombosis rate
24 months
Success of the procedure
24 months
Study Arms (2)
TITAN 2 stent - Hexacath France
EXPERIMENTALPatients receiving Titan 2 stents (percutaneous coronary intervention)
Cobalt-Chromium BMS - Any firm
ACTIVE COMPARATORPatients receiving Cobalt-Chromium Bare Metal Stents (free of any coating)(percutaneous coronary intervention)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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)
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hexacath, Francelead
Study Sites (42)
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
Hôpital Gabriel Montpied
Clermont-Ferrand, France
Hôpital Albert Schweitzer
Colmar, France
Ch Sud Francilien
Corbeil-Essonnes, France
Centre Hospitalier Laënnec
Creil, France
CHU de Grenoble
Grenoble, France
Groupe Hospitalier Mutualiste
Grenoble, France
Centre Hospitalier Général
Haguenau, France
Centre Hospitalier Départemental
La Roche-sur-Yon, France
Centre Hospitalier de Lagny
Lagny, France
Centre Hospitalier de Lille
Lille, France
HCL Bron
Lyon, France
HCL Croix-Rousse
Lyon, France
Clinique Beauregard
Marseille, France
Hôpital Nord
Marseille, France
Clinique Les Fontaines
Melun, France
Hôpital Emile Muller
Mulhouse, France
Nouvelles Cliniques Nantaises
Nantes, France
CHU Caremeau
Nîmes, France
Clinique Alleray Labrouste
Paris, France
HIA Val de Grâce
Paris, France
Hôpital Saint-Joseph
Paris, France
CH Pau
Pau, France
Clinique Saint-Martin
Pessac, France
Hôpital Claude Galien- ICPS
Quincy-sous-Sénart, France
Clinique Saint Laurent
Rennes, France
Clinique Saint-Hilaire
Rouen, France
CH Saint-Brieuc
Saint-Brieuc, France
CHI Toulon La Seyne
Toulon, France
Clinique Pasteur
Toulouse, France
Hôpital de Rangueil
Toulouse, France
CHRU Tours
Tours, France
CH Valence
Valence, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gilles RIOUFOL, Pr
Hospices Civils de Lyon- Bron - France
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2013
First Posted
August 7, 2013
Study Start
March 1, 2011
Primary Completion
December 1, 2015
Study Completion
March 1, 2016
Last Updated
January 8, 2014
Record last verified: 2014-01