Comparative Phase IV Study: Efficacy And Safety of TiTAN2 Versus COBALT-CHROME Stents- EVIDENCEII

Acute Coronary Syndrome Clinical Trial

— EVIDENCE II  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01918150
• Other study ID #: HXF-CT2-20111
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 2, 2013
• Last updated: January 7, 2014
• Start date: March 2011
• Est. completion date: March 2016

Study information

• Verified date: January 2014
• Source: Hexacath, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesFrance: French Data Protection AuthorityFrance: Conseil National de l'Ordre des Médecins
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1350
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Stable
• Myocardial Infarction
• Silent Myocardial Infarction
• Stable Angina

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Hexacath, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	24 months	No
Secondary	Target Lesion Revascularization (TLR ) rate	Any study stent restenosis leading to a procedure or a surgery to treat it.	24 months	Yes
Secondary	Stent thrombosis rate	Stent thrombosis will be evaluated as per the ARC classification (ie degree of evidence and time to event)	24 months	Yes
Secondary	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.	24 months	Yes