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

January 7, 2014 updated by: Hexacath, France

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.

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1350

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Albi, France
        • Clinique Claude Bernard
      • Amiens, France
        • Clinique de l'Europe
      • Amiens, France
        • Hopital Sud
      • Angers, France
        • CHU Angers
      • Avignon, France
        • CH Henri Duffaut
      • Bayonne, France
        • Clinique La Fourcade
      • Bois-Bernard, France
        • Polyclinique de Bois Bernard
      • Caen, France
        • CHU côte de Nacre
      • Cannes, France
        • Ch Cannes
      • Chartres, France
        • Centre Hospitalier Louis Pasteur
      • Clermont Ferrand, France
        • Hopital Gabriel Montpied
      • Colmar, France
        • Hôpital Albert Schweitzer
      • Corbeil-Essonnes, France
        • CH SUd Francilien
      • Creil, France
        • Centre Hospitalier LAENNEC
      • Grenoble, France
        • CHU de Grenoble
      • Grenoble, France
        • Groupe Hospitalier Mutualiste
      • Haguenau, France
        • Centre Hospitalier General
      • La Roche sur Yon, France
        • Centre Hospitalier departemental
      • Lagny, France
        • Centre Hospitalier de Lagny
      • Lille, France
        • Centre Hospitalier de Lille
      • Lyon, France
        • HCL Bron
      • Lyon, France
        • HCL Croix-Rousse
      • Marseille, France
        • Hôpital Nord
      • Marseille, France
        • Clinique Beauregard
      • Melun, France
        • Clinique Les Fontaines
      • Mulhouse, France
        • Hôpital Emile Muller
      • Nantes, France
        • Nouvelles Cliniques Nantaises
      • Nîmes, France
        • CHU Caremeau
      • Paris, France
        • Hôpital Saint-Joseph
      • Paris, France
        • HIA Val de Grâce
      • Paris, France
        • Clinique Alleray Labrouste
      • Pau, France
        • CH Pau
      • Pessac, France
        • Clinique Saint-Martin
      • Quincy-sous-Sénart, France
        • Hôpital Claude Galien- ICPS
      • Rennes, France
        • Clinique Saint Laurent
      • Rouen, France
        • Clinique Saint-Hilaire
      • Saint-Brieuc, France
        • CH Saint-Brieuc
      • Toulon, France
        • CHI Toulon La Seyne
      • Toulouse, France
        • Clinique Pasteur
      • Toulouse, France
        • Hôpital de Rangueil
      • Tours, France
        • CHRU Tours
      • Valence, France
        • CH Valence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TITAN 2 stent - Hexacath France
Patients receiving Titan 2 stents (percutaneous coronary 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.
ACTIVE_COMPARATOR: Cobalt-Chromium BMS - Any firm
Patients receiving Cobalt-Chromium Bare Metal Stents (free of any coating)(percutaneous coronary intervention)
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 24 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medico economic evaluation
Time Frame: 24 months

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
Target Lesion Revascularization (TLR ) rate
Time Frame: 24 months
Any study stent restenosis leading to a procedure or a surgery to treat it.
24 months
Stent thrombosis rate
Time Frame: 24 months
Stent thrombosis will be evaluated as per the ARC classification (ie degree of evidence and time to event)
24 months
Success of the procedure
Time Frame: 24 months

Defined as an efficient reintroduction of the blood flow in the target vessel post angioplasty.

It's a "YES/NO" question.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hexacath, France

Investigators

  • Principal Investigator: Gilles RIOUFOL, Pr, Hospices Civils de Lyon- Bron - France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

March 1, 2016

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (ESTIMATE)

August 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 8, 2014

Last Update Submitted That Met QC Criteria

January 7, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HXF-CT2-20111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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