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

Ischemic Heart Disease Clinical Trial

— PLATINUM+  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01342822
• Other study ID #: BSI-01
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 25, 2011
• Last updated: March 12, 2012
• Start date: October 2010
• Est. completion date: March 2014

Study information

• Verified date: March 2012
• Source: European Cardiovascular Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesSpain: Ministry of HealthItaly: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical 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 subjects will be screened per the protocol required inclusion/exclusion criteria.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2980
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Stenosis
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
France	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	Nimes
France	Clinique Saint-Pierre	Perpignan
France	Centre Privé Claude Galien	Quincy-sous-senart
France	Groupement de Coopération Sanitaire	St Nazaire
France	CHU Rangueil	Toulouse
France	Clinique Pasteur	Toulouse
Germany	Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Klinikum Leverkusen	Leverkusen
Germany	Kardiologische Praxis und Praxisklinik	München
Germany	Universitätsklinikum Ulm	Ulm
Italy	Azienda Ospedale "S.G. Moscati"	Avellino
Italy	Ospedale Civile di Legnano	Legnano
Italy	Ospedale Carlo Poma	Mantova
Italy	Azienda Ospedaliera di Padova	Padova
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
Macedonia, The Former Yugoslav R	University Clinic of Cardiology	Skopje
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Spain	Hospital Infanta Cristina	Badajoz
Spain	Hospital German Trias i Pujol	Badalona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Sant Pau i Sant Creu	Barcelona
Spain	Hospital General Yague	Burgos
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Virgen de la Arrixaca	Murcia
Spain	Hospital Valdecilla	Santander
Spain	Hospital del Mexoeiro	Vigo
Switzerland	University Hospital Fribourg	Fribourg
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
European Cardiovascular Research Center

Countries where clinical trial is conducted

France,  Germany,  Italy,  Macedonia, The Former Yugoslav Republic of,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes