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

NCT ID: NCT01342822

Last Updated: 2012-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2980 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2014-03-31

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.

Conditions

Ischemic Heart Disease; Coronary Artery Stenosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

PROMUS Element™

All patients enrolled will be randomized 2:1 to receive the PROMUS Element™ stent (N=1987)

Angioplasty (PROMUS Element™, and Xience™ Prime stent)

Intervention Type: 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.

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).

Angioplasty (PROMUS Element™, and Xience™ Prime stent)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

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. -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Cardiovascular Research Center

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique de l'Europe

Amiens, , France

Polyclinique de Bois Bernard

Bois-Bernard, , France

Clinique Saint Augustin

Bordeaux, , France

CHU Brest

Brest, , France

Clinique Saint-Martin

Caen, , France

CHG Chartres

Chartres, , France

CHU Grenoble

Grenoble, , France

CH Lagny

Lagny, , France

Hôpital privé Beauregard

Marseille, , France

Institut Hospitalier Jacques Cartier - ICPS

Massy, , France

Clinique les Fontaines

Melun, , France

Clinique du Millénaire

Montpellier, , France

Nouvelles Cliniques Nantaises NCN

Nantes, , France

Hôpital Privé Les Franciscaines

Nîmes, , France

Clinique Saint-Pierre

Perpignan, , France

Centre Privé Claude Galien

Quincy-sous-Sénart, , France

Groupement de Coopération Sanitaire

Saint-Nazaire, , France

Clinique Pasteur

Toulouse, , France

CHU Rangueil

Toulouse, , France

Herzzentrum Bad Krozingen

Bad Krozingen, , Germany

Klinikum Leverkusen

Leverkusen, , Germany

Kardiologische Praxis und Praxisklinik

München, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Azienda Ospedale "S.G. Moscati"

Avellino, , Italy

Ospedale Civile di Legnano

Legnano, , Italy

Ospedale Carlo Poma

Mantova, , Italy

Azienda Ospedaliera di Padova

Padua, , Italy

Azienda Ospedaliero-Universitaria Pisana - MCV I°

Pisa, , Italy

Azienda Ospedaliera "Ordine Mauriziano di Torino"

Torino, , Italy

Azienda ULSS 9 Treviso; Ospedale "S. Maria di Ca' Foncello"

Treviso, , Italy

Albert Schweitzer Ziekenhuis

Dordrecht, , Netherlands

University Clinic of Cardiology

Skopje, , North Macedonia

Hospital General Yague

Burgos, Spain, Spain

Hospital Infanta Cristina

Badajoz, , Spain

Hospital German Trias i Pujol

Badalona, , Spain

Hospital Sant Pau i Sant Creu

Barcelona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Virgen de la Arrixaca

Murcia, , Spain

Hospital Valdecilla

Santander, , Spain

Hospital del Mexoeiro

Vigo, , Spain

University Hospital Fribourg

Fribourg, , Switzerland

Royal Victoria Hospital

Belfast, , United Kingdom

Lancashire Cardiac Centre

Blackpool, , United Kingdom

Royal Sussex County Hospital

Brighton, , United Kingdom

St Thomas Hospital

London, , United Kingdom

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Craigavon Cardiac Centre

Portadown, , United Kingdom

Royal Victoria Hospital

Wolverhampton, , United Kingdom

Countries

France; Germany; Italy; Netherlands; North Macedonia; Spain; Switzerland; United Kingdom

Other Identifiers

BSI-01

Identifier Type: -

Identifier Source: org_study_id