Silent Myocardial InfarctionPhase 4EVIDENCE IINCT01918150
Comparative Phase IV Study: Efficacy And Safety of TiTAN2 Versus COBALT-CHROME Stents- EVIDENCEII
A Phase 4 study testing Titan 2 stents and Cobalt-Chromium Bare Metal Stents in people with Silent Myocardial Infarction and Stable Angina, run by Hexacath, France at 42 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Silent Myocardial Infarction, Stable Angina, Acute Coronary Syndrome
- What is being tested?
- Titan 2 stents and Cobalt-Chromium Bare Metal Stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,350 participants
- Where
- 42 sitesFrance
- Study dates
- Mar 2011to Mar 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
France42 sites
Clinique Claude Bernard
Albi
Clinique de l'Europe
Amiens
Hôpital Sud
Amiens
CHU Angers
Angers
CH Henri Duffaut
Avignon
Clinique La Fourcade
Bayonne
Polyclinique de Bois Bernard
Bois-Bernard
CHU Côte de Nacre
Caen
CH Cannes
Cannes
Centre hospitalier Louis Pasteur
Chartres
Hôpital Gabriel Montpied
Clermont-Ferrand
Hôpital Albert Schweitzer
Colmar
Ch Sud Francilien
Corbeil-Essonnes
Centre Hospitalier Laënnec
Creil
CHU de Grenoble
Grenoble
Groupe Hospitalier Mutualiste
Grenoble
Centre Hospitalier Général
Haguenau
Centre Hospitalier Départemental
La Roche-sur-Yon
Centre Hospitalier de Lagny
Lagny
Centre Hospitalier de Lille
Lille
HCL Bron
Lyon
HCL Croix-Rousse
Lyon
Clinique Beauregard
Marseille
Hôpital Nord
Marseille
Clinique Les Fontaines
Melun
Hôpital Emile Muller
Mulhouse
Nouvelles Cliniques Nantaises
Nantes
CHU Caremeau
Nîmes
Clinique Alleray Labrouste
Paris
HIA Val de Grâce
Paris
Hôpital Saint-Joseph
Paris
CH Pau
Pau
Clinique Saint-Martin
Pessac
Hôpital Claude Galien- ICPS
Quincy-sous-Sénart
Clinique Saint Laurent
Rennes
Clinique Saint-Hilaire
Rouen
CH Saint-Brieuc
Saint-Brieuc
CHI Toulon La Seyne
Toulon
Clinique Pasteur
Toulouse
Hôpital de Rangueil
Toulouse
CHRU Tours
Tours
CH Valence
Valence
About this study
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.
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).
Read the 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.
- Being tested
- Titan 2 stents, Cobalt-Chromium Bare Metal Stents
- Medical subject headings
- Angina, Stable, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titan 2 stentsDevice
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 StentsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TITAN 2 stent - Hexacath France | Experimental | Patients receiving Titan 2 stents (percutaneous coronary intervention) Receives: Device: Titan 2 stents |
| Cobalt-Chromium BMS - Any firm | Active comparator | Patients receiving Cobalt-Chromium Bare Metal Stents (free of any coating)(percutaneous coronary intervention) Receives: Device: Cobalt-Chromium Bare Metal Stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (4)
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.
Measured: 24 months
Target Lesion Revascularization (TLR ) rate
Any study stent restenosis leading to a procedure or a surgery to treat it.
Measured: 24 months
Stent thrombosis rate
Stent thrombosis will be evaluated as per the ARC classification (ie degree of evidence and time to event)
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startMar 2011
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Silent Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hexacath, France
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilles RIOUFOL, Pr, Principal investigator, Hospices Civils de Lyon- Bron - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918150
- Sponsor's protocol ID
- HXF-CT2-20111
- Acronym
- EVIDENCE II
- Status last verified
- Jan 2014
- First submitted
- 2 Aug 2013
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01918150
- Acronym / sponsor ID
- EVIDENCE II / HXF-CT2-20111
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- Hexacath, FranceIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TITAN 2 stent - Hexacath France | Experimental | Device: Titan 2 stentsPatients receiving Titan 2 stents (percutaneous coronary intervention) |
| Cobalt-Chromium BMS - Any firm | Active comparator | Device: Cobalt-Chromium Bare Metal StentsPatients receiving Cobalt-Chromium Bare Metal Stents (free of any coating)(percutaneous coronary intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (26 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titan 2 stentsThe 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. | Device | TITAN 2 stent - Hexacath France |
| Cobalt-Chromium Bare Metal StentsThe 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. | Device | Cobalt-Chromium BMS - Any firm |
Primary outcome
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.
4 secondary outcomes
Medico economic evaluation
Time frame: 24 months
Target Lesion Revascularization (TLR ) rate
Time frame: 24 months
Stent thrombosis rate
Time frame: 24 months
Success of the procedure
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles RIOUFOL, Pr principal investigator
Hospices Civils de Lyon- Bron - France
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Titan 2 stents and Cobalt-Chromium Bare Metal Stents in people with Silent Myocardial Infarction and Stable Angina, run by Hexacath, France at 42 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2014.