Ischemic Heart DiseasePLATINUM+NCT01342822
Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization
An observational study of Ischemic Heart Disease and Coronary Artery Stenosis, run by European Cardiovascular Research Center at 50 sites in 8 countries.
Trial summary
The PROMUS Element™ clinical trial (PLATINUM-PLUS) consists of a randomized controlled trial (RCT) in the European Union (EU) which will enroll approximately 2980 subjects (2:1 randomization PROMUS Element™: Xience™ Prime) in a Population of consecutive, all comers in the reimbursed indications per-country All… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Coronary Artery Stenosis
- What is being tested?
- Angioplasty (PROMUS Element™, and Xience™ Prime stent)
- Type of treatment
- Medical device
- How many people
- 2,980 participants
- Where
- 50 sitesin 8 countries
- Study dates
- Oct 2010to Mar 2014
- Phase
- Observational
- 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
Study population: All comers, in the indications reimbursed in the participating countries
Who may be able to join
- General Inclusion Criteria
- The patient must be ≥18 of age
- Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, and/or objective evidence of myocardial ischemia);
- Acceptable candidate for CABG;
- The patient is willing to comply with specified follow-up evaluations;
- The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC).
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- Angiographic Inclusion criteria:
- Single or multiple native coronary artery or saphenous vein graft lesions in single or multiple vessels;
- Patients with multi-lesion or multi-vessel coronary disease may undergo staged (planned) procedures within 30-days of the index procedure.
- Reference vessel diameter must be ≥2.25 to ≤ 4.25 mm by visual estimate.
Who cannot join
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
- Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated;
- Patient has other medical illness (e.g., cancer, known malignancy , congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
- Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, platinum chromium alloy, everolimus, and/or contrast sensitivity that cannot be adequately pre-medicated;
- Patient with LVEF <20%, cardiogenic shock, or hemodynamic compromise requiring pressors or inotropes or mechanical support devices
- Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
- Currently participating in another investigational drug or device study. -
Trial locations and contacts
50 sites in 8 countries.
50 sites in 8 countries
France19 sites
Clinique de l'Europe
Amiens, 80090
Polyclinique de Bois Bernard
Bois-Bernard, 62320
Clinique Saint Augustin
Bordeaux, 33000
CHU Brest
Brest, 29609
Clinique Saint-Martin
Caen, 14050
CHG Chartres
Chartres, 28018
CHU Grenoble
Grenoble, 38043
CH Lagny
Lagny, 77405
Hôpital privé Beauregard
Marseille, 13012
Institut Hospitalier Jacques Cartier - ICPS
Massy, 91300
Clinique les Fontaines
Melun, 77007
Clinique du Millénaire
Montpellier, France
Nouvelles Cliniques Nantaises NCN
Nantes, 44277
Hôpital Privé Les Franciscaines
Nîmes, 30000
Clinique Saint-Pierre
Perpignan, 66012
Centre Privé Claude Galien
Quincy-sous-Sénart, 91480
Groupement de Coopération Sanitaire
Saint-Nazaire
Clinique Pasteur
Toulouse, 31076
CHU Rangueil
Toulouse, 31403
Spain10 sites
Hospital Infanta Cristina
Badajoz, 06005
Hospital German Trias i Pujol
Badalona, 08916
Hospital Sant Pau i Sant Creu
Barcelona, 08025
Hospital del Mar
Barcelona
Hospital General Yague
Burgos, Spain, 09005
Hospital Universitario 12 de Octubre
Madrid, 028026
Hospital Clinico San Carlos
Madrid, 28040
Hospital Virgen de la Arrixaca
Murcia, 030120
Hospital Valdecilla
Santander, 039008
Hospital del Mexoeiro
Vigo, 36200
Italy7 sites
Azienda Ospedale "S.G. Moscati"
Avellino
Ospedale Civile di Legnano
Legnano
Ospedale Carlo Poma
Mantua
Azienda Ospedaliera di Padova
Padova
Azienda Ospedaliero-Universitaria Pisana - MCV I°
Pisa
Azienda Ospedaliera "Ordine Mauriziano di Torino"
Torino
Azienda ULSS 9 Treviso; Ospedale "S. Maria di Ca' Foncello"
Treviso
United Kingdom7 sites
Royal Victoria Hospital
Belfast
Lancashire Cardiac Centre
Blackpool
Royal Sussex County Hospital
Brighton
St Thomas Hospital
London
Freeman Hospital
Newcastle upon Tyne
Craigavon Cardiac Centre
Portadown
Royal Victoria Hospital
Wolverhampton
Germany4 sites
Herzzentrum Bad Krozingen
Bad Krozingen, 79189
Klinikum Leverkusen
Leverkusen, 51375
Kardiologische Praxis und Praxisklinik
München, 81379
Universitätsklinikum Ulm
Ulm, 89081
About this study
Official title: A Prospective, Randomized, Multi-center Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization in a Population of Unrestricted Patients
The PROMUS Element™ clinical trial (PLATINUM-PLUS) consists of a randomized controlled trial (RCT) in the European Union (EU) which will enroll approximately 2980 subjects (2:1 randomization PROMUS Element™: Xience™ Prime) in a Population of consecutive, all comers in the reimbursed indications per-country
All subjects will be screened per the protocol required inclusion/exclusion criteria.
Read the detailed description
The PLATINUM-PLUS trial will investigate in a broad patient and lesion population, the CE Mark approved PROMUS Element™ Everolimus-Eluting Coronary Stent System (PROMUS Element), which combines the Element™ stent (the latest generation stent from Boston Scientific Corporation [BSC, Natick, Massachusetts, United States]), everolimus, and the poly (n butyl methacrylate) (PBMA) and poly (vinylidene fluoride co hexafluoropropylene) (PVDF-HFP) polymers. The PROMUS Element, received CE Mark on November 3rd 2009; it is currently under investigation in the PLATINUM clinical trial, and has great promise as it combines BSC's novel stent technology with the everolimus drug and polymers that have demonstrated excellent performance in the SPIRIT clinical program.
PROMUS Element comprises the following key components: everolimus, 2 polymers, and the Element stent component. The same everolimus and polymer combination is commercially available in many countries on the MULTI-LINK VISION™ stent. It is manufactured and distributed by Abbott as the XIENCE™ V Everolimus Eluting Coronary Stent System (XIENCE V), and also distributed by BSC as the identical stent system, also manufactured by Abbott, as the PROMUS™ Everolimus-Eluting Coronary Stent System (PROMUS). The names XIENCE V and PROMUS are used synonymously within this protocol.
While PROMUS Element is a new DES system, its constituent parts are either approved by the Food and Drug Administration (FDA, i.e., drug and polymers from PROMUS, P070015), are under investigation in an FDA-approved trial (i.e., Element stent component in the PERSEUS trial, G060237), or have received an approvable letter from the FDA. The balloon component material of the PROMUS Element delivery system is the same as that used in TAXUS Liberté (P060008), which received an approvable letter on February 11, 2008. The PROMUS Element stent delivery system is from the Apex™ Monorail™ PTCA Dilatation Catheter (P860019/S208), which received an approvable letter on October 24, 2006. Table 1 compares the TAXUS Express2, TAXUS Liberté, and PROMUS Element stent systems.
- Conditions
- Ischemic Heart Disease, Coronary Artery Stenosis
- Being tested
- Angioplasty (PROMUS Element™, and Xience™ Prime stent)
- Keywords
- Heart disease, Coronary Revascularization
- Medical subject headings
- Myocardial Ischemia, Coronary Stenosis, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angioplasty (PROMUS Element™, and Xience™ Prime stent)Device
Patients with symptomatic ischemic heart disease due to stenotic lesions amenable to percutaneous treatment with a drug eluting stent in a consecutive unselected patient population, provided that the proposed research use of the product is consistent with the approved (labeled) uses of such product and with the reimbursed indications (in countries where reimbursement procedure applies, eg France) and does not violate any other applicable law, regulation or ethical directive/code.
| Study group | Role | What they receive |
|---|---|---|
| PROMUS Element™ | All patients enrolled will be randomized 2:1 to receive the PROMUS Element™ stent (N=1987) Receives: Device: Angioplasty (PROMUS Element™, and Xience™ Prime stent) | |
| Xience™ Prime stent | All patients enrolled will be randomized 2:1 to receive the PROMUS Element™ stent (N=1987) versus the Xience™ Prime Stent (N=993). Receives: Device: Angioplasty (PROMUS Element™, and Xience™ Prime stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel failure (TVF)
Target Vessel failure (TVF) of the PROMUS Element™ Everolimus-Eluting Coronary Stent at 12 months post-procedure. TVF is defined as any ischemia-driven revascularization of the target Vessel (TVR), MI (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Measured: 12 months
Secondary outcomes (1)
Clinical endpoints
Ischemia Driven TLR and TVR rate, TLF rate: defined as any ischemia-driven TLR, MI (Q-wave and non-Q-wave)related to the target vessel, or cardiac death related to the target vessel MI rate: Q-wave and non-Q-wave, cumulative and individual, Cardiac death rate, Non-cardiac death rate, All death or MI rate All Death/MI/TVR rate, MACE rate defined as a composite of death, MI (Q wave or non-Q wave), emergent CABG, or TLR by repeat PTCA or CABG. Stent Thrombosis (ST)rate.
Measured: 30 days, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startOct 2010
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Cardiovascular Research Center
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342822
- Sponsor's protocol ID
- BSI-01
- Acronym
- PLATINUM+
- Status last verified
- Mar 2012
- First submitted
- 25 Apr 2011
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-center Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization in a Population of Unrestricted Patients
- ClinicalTrials.gov ID
- NCT01342822
- Acronym / sponsor ID
- PLATINUM+ / BSI-01
- Conditions
- Ischemic Heart Disease, Coronary Artery Stenosis
- Keywords
- Heart disease, Coronary Revascularization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,980 participants (estimated)
- Lead sponsor
- European Cardiovascular Research CenterResearch network
- Study start
- Oct 2010
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 27 Apr 2011 (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 PROMUS Element™ clinical trial (PLATINUM-PLUS) consists of a randomized controlled trial (RCT) in the European Union (EU) which will enroll approximately 2980 subjects (2:1 randomization PROMUS Element™: Xience™ Prime) in a Population of consecutive, all comers in the reimbursed indications per-country
All subjects will be screened per the protocol required inclusion/exclusion criteria.
Detailed description
The PLATINUM-PLUS trial will investigate in a broad patient and lesion population, the CE Mark approved PROMUS Element™ Everolimus-Eluting Coronary Stent System (PROMUS Element), which combines the Element™ stent (the latest generation stent from Boston Scientific Corporation [BSC, Natick, Massachusetts, United States]), everolimus, and the poly (n butyl methacrylate) (PBMA) and poly (vinylidene fluoride co hexafluoropropylene) (PVDF-HFP) polymers. The PROMUS Element, received CE Mark on November 3rd 2009; it is currently under investigation in the PLATINUM clinical trial, and has great promise as it combines BSC's novel stent technology with the everolimus drug and polymers that have demonstrated excellent performance in the SPIRIT clinical program.
PROMUS Element comprises the following key components: everolimus, 2 polymers, and the Element stent component. The same everolimus and polymer combination is commercially available in many countries on the MULTI-LINK VISION™ stent. It is manufactured and distributed by Abbott as the XIENCE™ V Everolimus Eluting Coronary Stent System (XIENCE V), and also distributed by BSC as the identical stent system, also manufactured by Abbott, as the PROMUS™ Everolimus-Eluting Coronary Stent System (PROMUS). The names XIENCE V and PROMUS are used synonymously within this protocol.
While PROMUS Element is a new DES system, its constituent parts are either approved by the Food and Drug Administration (FDA, i.e., drug and polymers from PROMUS, P070015), are under investigation in an FDA-approved trial (i.e., Element stent component in the PERSEUS trial, G060237), or have received an approvable letter from the FDA. The balloon component material of the PROMUS Element delivery system is the same as that used in TAXUS Liberté (P060008), which received an approvable letter on February 11, 2008. The PROMUS Element stent delivery system is from the Apex™ Monorail™ PTCA Dilatation Catheter (P860019/S208), which received an approvable letter on October 24, 2006. Table 1 compares the TAXUS Express2, TAXUS Liberté, and PROMUS Element stent systems.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROMUS Element™ | – | Device: Angioplasty (PROMUS Element™, and Xience™ Prime stent)All patients enrolled will be randomized 2:1 to receive the PROMUS Element™ stent (N=1987) |
| Xience™ Prime stent | – | Device: Angioplasty (PROMUS Element™, and Xience™ Prime stent)All patients enrolled will be randomized 2:1 to receive the PROMUS Element™ stent (N=1987) versus the Xience™ Prime Stent (N=993). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All comers, in the indications reimbursed in the participating countries
Key inclusion criteria (10 listed)
- General Inclusion Criteria
- The patient must be ≥18 of age
- Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, and/or objective evidence of myocardial ischemia);
- Acceptable candidate for CABG;
- The patient is willing to comply with specified follow-up evaluations;
Key exclusion criteria (7 listed)
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
- Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated;
- Patient has other medical illness (e.g., cancer, known malignancy , congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
- Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, platinum chromium alloy, everolimus, and/or contrast sensitivity that cannot be adequately pre-medicated;
- Patient with LVEF <20%, cardiogenic shock, or hemodynamic compromise requiring pressors or inotropes or mechanical support devices
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 |
|---|---|---|
| Angioplasty (PROMUS Element™, and Xience™ Prime stent)Patients with symptomatic ischemic heart disease due to stenotic lesions amenable to percutaneous treatment with a drug eluting stent in a consecutive unselected patient population, provided that the proposed research use of the product is consistent with the approved (labeled) uses of such product and with the reimbursed indications (in countries where reimbursement procedure applies, eg France) and does not violate any other applicable law, regulation or ethical directive/code. | Device | PROMUS Element™, Xience™ Prime stent |
Primary outcome
Target Vessel failure (TVF)
Time frame: 12 months
Target Vessel failure (TVF) of the PROMUS Element™ Everolimus-Eluting Coronary Stent at 12 months post-procedure. TVF is defined as any ischemia-driven revascularization of the target Vessel (TVR), MI (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
1 secondary outcome
Clinical endpoints
Time frame: 30 days, 12 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Coronary Artery Stenosis, run by European Cardiovascular Research Center at 50 sites in 8 countries.
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 10 inclusion and 7 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 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in France, Spain, Italy, United Kingdom, Germany and 3 more countries. 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.
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?
Target Vessel failure (TVF) (time frame: 12 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 13 Mar 2012.