Comparative Phase IV Study: Efficacy And Safety of TiTAN2 Versus COBALT-CHROME Stents- EVIDENCEII
NCT ID: NCT01918150
Last Updated: 2014-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
1350 participants
INTERVENTIONAL
2011-03-31
2016-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
European Multicenter, Randomized, Comparative Efficacy/Safety Study of the Mar-Tyn TiN-Coated Stent
NCT00637104
Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent
NCT02014818
The Titan Versus Everolimus Intracoronary Stent (Xience V) in Diabetic Patients
NCT01510509
Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion?
NCT00852215
Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN studIeS for TreatMent of Acute Myocardial InfarctionTreatment of ST-elevation Acute Myocardial Infarction
NCT02014753
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TITAN 2 stent - Hexacath France
Patients receiving Titan 2 stents (percutaneous coronary intervention)
Titan 2 stents
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.
Cobalt-Chromium BMS - Any firm
Patients receiving Cobalt-Chromium Bare Metal Stents (free of any coating)(percutaneous coronary intervention)
Cobalt-Chromium Bare Metal Stents
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Titan 2 stents
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.
Cobalt-Chromium Bare Metal Stents
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hexacath, France
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gilles RIOUFOL, Pr
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon- Bron - France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HXF-CT2-20111
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.