Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization (PLATINUM+)

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Heart Disease; Coronary Artery Stenosis
• Intervention / Treatment: Device: Angioplasty (PROMUS Element™, and Xience™ Prime stent)

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 Type: Observational
• Enrollment (Anticipated): 2980

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80090
    • Clinique de l'Europe
  • Bois-bernard, France, 62320
    • Polyclinique de Bois Bernard
  • Bordeaux, France, 33000
    • Clinique Saint Augustin
  • Brest, France, 29609
    • CHU Brest
  • Caen, France, 14050
    • Clinique Saint-Martin
  • Chartres, France, 28018
    • CHG Chartres
  • Grenoble, France, 38043
    • CHU Grenoble
  • Lagny, France, 77405
    • CH Lagny
  • Marseille, France, 13012
    • Hôpital Privé Beauregard
  • Massy, France, 91300
    • Institut Hospitalier Jacques Cartier - ICPS
  • Melun, France, 77007
    • Clinique les Fontaines
  • Montpellier, France, France
    • Clinique du Millénaire
  • Nantes, France, 44277
    • Nouvelles Cliniques Nantaises NCN
  • Nimes, France, 30000
    • Hôpital Privé Les Franciscaines
  • Perpignan, France, 66012
    • Clinique Saint-Pierre
  • Quincy-sous-senart, France, 91480
    • Centre Privé Claude Galien
  • St Nazaire, France
    • Groupement de coopération sanitaire
  • Toulouse, France, 31403
    • CHU Rangueil
  • Toulouse, France, 31076
    • Clinique Pasteur
• Germany
  • Bad Krozingen, Germany, 79189
    • Herzzentrum Bad Krozingen
  • Leverkusen, Germany, 51375
    • Klinikum Leverkusen
  • München, Germany, 81379
    • Kardiologische Praxis und Praxisklinik
  • Ulm, Germany, 89081
    • Universitatsklinikum Ulm
• Italy
  • Avellino, Italy
    • Azienda Ospedale "S.G. Moscati"
  • Legnano, Italy
    • Ospedale Civile di Legnano
  • Mantova, Italy
    • Ospedale Carlo Poma
  • Padova, Italy
    • Azienda Ospedaliera di Padova
  • Pisa, Italy
    • Azienda Ospedaliero-Universitaria Pisana - MCV I°
  • Torino, Italy
    • Azienda Ospedaliera "Ordine Mauriziano di Torino"
  • Treviso, Italy
    • Azienda ULSS 9 Treviso; Ospedale "S. Maria di Ca' Foncello"
• Macedonia, The Former Yugoslav Republic of
  • Skopje, Macedonia, The Former Yugoslav Republic of
    • University Clinic of Cardiology
• Netherlands
  • Dordrecht, Netherlands
    • Albert Schweitzer Ziekenhuis
• Spain
  • Badajoz, Spain, 06005
    • Hospital Infanta Cristina
  • Badalona, Spain, 08916
    • Hospital German Trias i Pujol
  • Barcelona, Spain
    • Hospital del Mar
  • Barcelona, Spain, 08025
    • Hospital Sant Pau i Sant Creu
  • Burgos, Spain, 09005
    • Hospital General Yagüe
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 028026
    • Hospital Universitario 12 de octubre
  • Murcia, Spain, 030120
    • Hospital Virgen de la Arrixaca
  • Santander, Spain, 039008
    • Hospital Valdecilla
  • Vigo, Spain, 36200
    • Hospital del Mexoeiro
• Switzerland
  • Fribourg, Switzerland
    • University Hospital Fribourg
• United Kingdom
  • Belfast, United Kingdom
    • Royal Victoria Hospital
  • Blackpool, United Kingdom
    • Lancashire Cardiac Centre
  • Brighton, United Kingdom
    • Royal Sussex County Hospital
  • London, United Kingdom
    • St Thomas Hospital
  • Newcastle Upon Tyne, United Kingdom
    • Freeman Hospital
  • Portadown, United Kingdom
    • Craigavon Cardiac Centre
  • Wolverhampton, United Kingdom
    • Royal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All comers, in the indications reimbursed in the participating countries

Description

Inclusion Criteria:

General Inclusion Criteria

1. The patient must be ≥18 of age
2. Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, and/or objective evidence of myocardial ischemia);
3. Acceptable candidate for CABG;
4. The patient is willing to comply with specified follow-up evaluations;

5. 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).

   Angiographic Inclusion criteria:

6. Single or multiple native coronary artery or saphenous vein graft lesions in single or multiple vessels;
7. Patients with multi-lesion or multi-vessel coronary disease may undergo staged (planned) procedures within 30-days of the index procedure.
8. Reference vessel diameter must be ≥2.25 to ≤ 4.25 mm by visual estimate.

Exclusion Criteria:

1. 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;
2. Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated;
3. 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);
4. 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;
5. Patient with LVEF <20%, cardiogenic shock, or hemodynamic compromise requiring pressors or inotropes or mechanical support devices
6. Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
7. Currently participating in another investigational drug or device study. -

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PROMUS Element™; All patients enrolled will be randomized 2:1 to receive the PROMUS Element™ stent (N=1987)	Device: 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.
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).	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days, 12 months and 24 months

Collaborators and Investigators

• Sponsor: European Cardiovascular Research Center

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ANTICIPATED): March 1, 2014
• Study Completion (ANTICIPATED): March 1, 2014

Study Registration Dates

• First Submitted: April 25, 2011
• First Submitted That Met QC Criteria: April 26, 2011
• First Posted (ESTIMATE): April 27, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 13, 2012
• Last Update Submitted That Met QC Criteria: March 12, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Heart disease; Coronary Revascularization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Stenosis
• Other Study ID Numbers: BSI-01