Clinical trial NCT01918150: Comparative Phase IV Study: Efficacy And Safety of TiTAN2 Versus COBALT-CHROME Stents- EVIDENCEII
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Silent Myocardial Infarction
Stable Angina
Acute Coronary Syndrome
Lead sponsor: Hexacath, France
Sponsor class: INDUSTRY
First posted: 2013-08-07
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: MACE
timeFrame: 24 months
Secondary outcomes:
measure: Medico economic evaluation
timeFrame: 24 months
measure: Target Lesion Revascularization (TLR ) rate
timeFrame: 24 months
measure: Stent thrombosis rate
timeFrame: 24 months
measure: Success of the procedure
timeFrame: 24 months
Other outcomes:
Locations:
city: Albi
country: France
facility: Clinique Claude Bernard
city: Amiens
country: France
facility: Clinique de l'Europe
city: Amiens
country: France
facility: Hôpital Sud
city: Angers
country: France
facility: CHU Angers
city: Avignon
country: France
facility: CH Henri Duffaut
city: Bayonne
country: France
facility: Clinique La Fourcade
city: Bois-Bernard
country: France
facility: Polyclinique de Bois Bernard
city: Caen
country: France
facility: CHU Côte de Nacre
city: Cannes
country: France
facility: CH Cannes
city: Chartres
country: France
facility: Centre hospitalier Louis Pasteur
city: Clermont Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Colmar
country: France
facility: Hôpital Albert Schweitzer
city: Corbeil-Essonnes
country: France
facility: Ch Sud Francilien
city: Creil
country: France
facility: Centre Hospitalier Laënnec
city: Grenoble
country: France
facility: CHU de Grenoble
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste
city: Haguenau
country: France
facility: Centre Hospitalier Général
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départemental
city: Lagny
country: France
facility: Centre Hospitalier de Lagny
city: Lille
country: France
facility: Centre Hospitalier de Lille
city: Lyon
country: France
facility: HCL Bron
city: Lyon
country: France
facility: HCL Croix-Rousse
city: Marseille
country: France
facility: Clinique Beauregard
city: Marseille
country: France
facility: Hôpital Nord
city: Melun
country: France
facility: Clinique Les Fontaines
city: Mulhouse
country: France
facility: Hôpital Emile Muller
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Nîmes
country: France
facility: CHU Caremeau
city: Paris
country: France
facility: Clinique Alleray Labrouste
city: Paris
country: France
facility: HIA Val de Grâce
city: Paris
country: France
facility: Hôpital Saint-Joseph
city: Pau
country: France
facility: CH Pau
city: Pessac
country: France
facility: Clinique Saint-Martin
city: Quincy-sous-Sénart
country: France
facility: Hôpital Claude Galien- ICPS
city: Rennes
country: France
facility: Clinique Saint Laurent
city: Rouen
country: France
facility: Clinique Saint-Hilaire
city: Saint-Brieuc
country: France
facility: CH Saint-Brieuc
city: Toulon
country: France
facility: CHI Toulon La Seyne
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Hôpital de Rangueil
city: Tours
country: France
facility: CHRU Tours
city: Valence
country: France
facility: CH Valence
Study officials:
affiliation: Hospices Civils de Lyon- Bron - France
name: Gilles RIOUFOL, Pr
role: PRINCIPAL_INVESTIGATOR
References: