Clinical trial NCT01342822: Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Heart Disease
Coronary Artery Stenosis
Keywords: Heart disease
Coronary Revascularization
Lead sponsor: European Cardiovascular Research Center
Sponsor class: NETWORK
First posted: 2011-04-27
Enrollment: 2980
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All comers, in the indications reimbursed in the participating countries

Brief 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 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.

Eligibility criteria: 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. -

Primary outcomes:
measure: Target Vessel failure (TVF)
timeFrame: 12 months
Secondary outcomes:
measure: Clinical endpoints
timeFrame: 30 days, 12 months and 24 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Clinique de l'Europe
city: Bois-bernard
country: France
facility: Polyclinique de Bois Bernard
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Brest
country: France
facility: CHU Brest
city: Caen
country: France
facility: Clinique Saint-Martin
city: Chartres
country: France
facility: CHG Chartres
city: Grenoble
country: France
facility: CHU Grenoble
city: Lagny
country: France
facility: CH Lagny
city: Marseille
country: France
facility: Hôpital privé Beauregard
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier - ICPS
city: Melun
country: France
facility: Clinique les Fontaines
city: Montpellier
country: France
facility: Clinique du Millénaire
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises NCN
city: Nimes
country: France
facility: Hôpital Privé Les Franciscaines
city: Perpignan
country: France
facility: Clinique Saint-Pierre
city: Quincy-sous-senart
country: France
facility: Centre Privé Claude Galien
city: St Nazaire
country: France
facility: Groupement de Coopération Sanitaire
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: CHU Rangueil
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen
city: München
country: Germany
facility: Kardiologische Praxis und Praxisklinik
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Avellino
country: Italy
facility: Azienda Ospedale "S.G. Moscati"
city: Legnano
country: Italy
facility: Ospedale Civile di Legnano
city: Mantova
country: Italy
facility: Ospedale Carlo Poma
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana - MCV I°
city: Torino
country: Italy
facility: Azienda Ospedaliera "Ordine Mauriziano di Torino"
city: Treviso
country: Italy
facility: Azienda ULSS 9 Treviso; Ospedale "S. Maria di Ca' Foncello"
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: University Clinic of Cardiology
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Badalona
country: Spain
facility: Hospital German Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Sant Pau i Sant Creu
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Burgos
country: Spain
facility: Hospital General Yague
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Santander
country: Spain
facility: Hospital Valdecilla
city: Vigo
country: Spain
facility: Hospital del Mexoeiro
city: Fribourg
country: Switzerland
facility: University Hospital Fribourg
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Blackpool
country: United Kingdom
facility: Lancashire Cardiac Centre
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: London
country: United Kingdom
facility: St Thomas Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Portadown
country: United Kingdom
facility: Craigavon Cardiac Centre
city: Wolverhampton
country: United Kingdom
facility: Royal Victoria Hospital
Study officials:
References: