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

Primary Purpose

Silent Myocardial Infarction, Stable Angina, Acute Coronary Syndrome

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Titan 2 stents
Cobalt-Chromium Bare Metal Stents
Sponsored by
Hexacath, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Silent Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique Claude Bernard
  • Clinique de l'Europe
  • Hôpital Sud
  • CHU Angers
  • CH Henri Duffaut
  • Clinique La Fourcade
  • Polyclinique de Bois Bernard
  • CHU Côte de Nacre
  • CH Cannes
  • Centre hospitalier Louis Pasteur
  • Hôpital Gabriel Montpied
  • Hôpital Albert Schweitzer
  • Ch Sud Francilien
  • Centre Hospitalier Laënnec
  • CHU de Grenoble
  • Groupe Hospitalier Mutualiste
  • Centre Hospitalier Général
  • Centre Hospitalier Départemental
  • Centre Hospitalier de Lagny
  • Centre Hospitalier de Lille
  • HCL Bron
  • HCL Croix-Rousse
  • Clinique Beauregard
  • Hôpital Nord
  • Clinique Les Fontaines
  • Hôpital Emile Muller
  • Nouvelles Cliniques Nantaises
  • CHU Caremeau
  • Clinique Alleray Labrouste
  • HIA Val de Grâce
  • Hôpital Saint-Joseph
  • CH Pau
  • Clinique Saint-Martin
  • Hôpital Claude Galien- ICPS
  • Clinique Saint Laurent
  • Clinique Saint-Hilaire
  • CH Saint-Brieuc
  • CHI Toulon La Seyne
  • Clinique Pasteur
  • Hôpital de Rangueil
  • CHRU Tours
  • CH Valence

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TITAN 2 stent - Hexacath France

Cobalt-Chromium BMS - Any firm

Arm Description

Patients receiving Titan 2 stents (percutaneous coronary intervention)

Patients receiving Cobalt-Chromium Bare Metal Stents (free of any coating)(percutaneous coronary intervention)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 2, 2013
Last Updated
January 7, 2014
Sponsor
Hexacath, France
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1. Study Identification

Unique Protocol Identification Number
NCT01918150
Brief Title
Comparative Phase IV Study: Efficacy And Safety of TiTAN2 Versus COBALT-CHROME Stents- EVIDENCEII
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hexacath, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Silent Myocardial Infarction, Stable Angina, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TITAN 2 stent - Hexacath France
Arm Type
Experimental
Arm Description
Patients receiving Titan 2 stents (percutaneous coronary intervention)
Arm Title
Cobalt-Chromium BMS - Any firm
Arm Type
Active Comparator
Arm Description
Patients receiving Cobalt-Chromium Bare Metal Stents (free of any coating)(percutaneous coronary intervention)
Intervention Type
Device
Intervention Name(s)
Titan 2 stents
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cobalt-Chromium Bare Metal Stents
Intervention Description
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.
Primary Outcome Measure Information:
Title
MACE
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Medico economic evaluation
Description
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.
Time Frame
24 months
Title
Target Lesion Revascularization (TLR ) rate
Description
Any study stent restenosis leading to a procedure or a surgery to treat it.
Time Frame
24 months
Title
Stent thrombosis rate
Description
Stent thrombosis will be evaluated as per the ARC classification (ie degree of evidence and time to event)
Time Frame
24 months
Title
Success of the procedure
Description
Defined as an efficient reintroduction of the blood flow in the target vessel post angioplasty. It's a "YES/NO" question.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles RIOUFOL, Pr
Organizational Affiliation
Hospices Civils de Lyon- Bron - France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Claude Bernard
City
Albi
Country
France
Facility Name
Clinique de l'Europe
City
Amiens
Country
France
Facility Name
Hôpital Sud
City
Amiens
Country
France
Facility Name
CHU Angers
City
Angers
Country
France
Facility Name
CH Henri Duffaut
City
Avignon
Country
France
Facility Name
Clinique La Fourcade
City
Bayonne
Country
France
Facility Name
Polyclinique de Bois Bernard
City
Bois-Bernard
Country
France
Facility Name
CHU Côte de Nacre
City
Caen
Country
France
Facility Name
CH Cannes
City
Cannes
Country
France
Facility Name
Centre hospitalier Louis Pasteur
City
Chartres
Country
France
Facility Name
Hôpital Gabriel Montpied
City
Clermont Ferrand
Country
France
Facility Name
Hôpital Albert Schweitzer
City
Colmar
Country
France
Facility Name
Ch Sud Francilien
City
Corbeil-Essonnes
Country
France
Facility Name
Centre Hospitalier Laënnec
City
Creil
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Facility Name
Groupe Hospitalier Mutualiste
City
Grenoble
Country
France
Facility Name
Centre Hospitalier Général
City
Haguenau
Country
France
Facility Name
Centre Hospitalier Départemental
City
La Roche sur Yon
Country
France
Facility Name
Centre Hospitalier de Lagny
City
Lagny
Country
France
Facility Name
Centre Hospitalier de Lille
City
Lille
Country
France
Facility Name
HCL Bron
City
Lyon
Country
France
Facility Name
HCL Croix-Rousse
City
Lyon
Country
France
Facility Name
Clinique Beauregard
City
Marseille
Country
France
Facility Name
Hôpital Nord
City
Marseille
Country
France
Facility Name
Clinique Les Fontaines
City
Melun
Country
France
Facility Name
Hôpital Emile Muller
City
Mulhouse
Country
France
Facility Name
Nouvelles Cliniques Nantaises
City
Nantes
Country
France
Facility Name
CHU Caremeau
City
Nîmes
Country
France
Facility Name
Clinique Alleray Labrouste
City
Paris
Country
France
Facility Name
HIA Val de Grâce
City
Paris
Country
France
Facility Name
Hôpital Saint-Joseph
City
Paris
Country
France
Facility Name
CH Pau
City
Pau
Country
France
Facility Name
Clinique Saint-Martin
City
Pessac
Country
France
Facility Name
Hôpital Claude Galien- ICPS
City
Quincy-sous-Sénart
Country
France
Facility Name
Clinique Saint Laurent
City
Rennes
Country
France
Facility Name
Clinique Saint-Hilaire
City
Rouen
Country
France
Facility Name
CH Saint-Brieuc
City
Saint-Brieuc
Country
France
Facility Name
CHI Toulon La Seyne
City
Toulon
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Facility Name
Hôpital de Rangueil
City
Toulouse
Country
France
Facility Name
CHRU Tours
City
Tours
Country
France
Facility Name
CH Valence
City
Valence
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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