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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hexacath, France
ClinicalTrials.gov Identifier:
NCT01918150
First received: August 2, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Silent Myocardial Infarction
Stable Angina
Acute Coronary Syndrome
Device: Titan 2 stents
Device: Cobalt-Chromium Bare Metal Stents
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Hexacath, France:

Primary Outcome Measures:
  • MACE [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Medico economic evaluation [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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.


  • Target Lesion Revascularization (TLR ) rate [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Any study stent restenosis leading to a procedure or a surgery to treat it.

  • Stent thrombosis rate [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Stent thrombosis will be evaluated as per the ARC classification (ie degree of evidence and time to event)

  • Success of the procedure [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

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

    It's a "YES/NO" question.



Estimated Enrollment: 1350
Study Start Date: March 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918150

Locations
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
Groupe Hospitalier Mutualiste
Grenoble, France
CHU de Grenoble
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
HIA Val de Grâce
Paris, France
Clinique Alleray Labrouste
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
Hôpital de Rangueil
Toulouse, France
Clinique Pasteur
Toulouse, France
CHRU Tours
Tours, France
CH Valence
Valence, France
Sponsors and Collaborators
Hexacath, France
Investigators
Principal Investigator: Gilles RIOUFOL, Pr Hospices Civils de Lyon- Bron - France
  More Information

No publications provided

Responsible Party: Hexacath, France
ClinicalTrials.gov Identifier: NCT01918150     History of Changes
Other Study ID Numbers: HXF-CT2-20111
Study First Received: August 2, 2013
Last Updated: January 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
France: French Data Protection Authority
France: Conseil National de l'Ordre des Médecins

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina, Stable
Infarction
Myocardial Infarction
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Chromium
Cobalt
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on October 20, 2014