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

NCT01342822 | Unknown DMC

• 1 other identifier: BSI-01
• Study Type: observational
• Target: 2,980
• Locations: 8 countries
• Sites: 50

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.

Conditions

Ischemic Heart Disease; Coronary Artery Stenosis

Keywords

Heart disease; Coronary Revascularization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical endpoints

  30 days, 12 months and 24 months

Study Arms (2)

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)

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)

Interventions

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.

PROMUS Element™; Xience™ Prime stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All comers, in the indications reimbursed in the participating countries

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• European Cardiovascular Research Center: lead

Study Sites (50)

Clinique de l'Europe

Amiens, 80090, France

Location

Polyclinique de Bois Bernard

Bois-Bernard, 62320, France

Location

Clinique Saint Augustin

Bordeaux, 33000, France

Location

CHU Brest

Brest, 29609, France

Location

Clinique Saint-Martin

Caen, 14050, France

Location

CHG Chartres

Chartres, 28018, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

CH Lagny

Lagny, 77405, France

Location

Hôpital privé Beauregard

Marseille, 13012, France

Location

Institut Hospitalier Jacques Cartier - ICPS

Massy, 91300, France

Location

Clinique les Fontaines

Melun, 77007, France

Location

Clinique du Millénaire

Montpellier, France, France

Location

Nouvelles Cliniques Nantaises NCN

Nantes, 44277, France

Location

Hôpital Privé Les Franciscaines

Nîmes, 30000, France

Location

Clinique Saint-Pierre

Perpignan, 66012, France

Location

Centre Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

Groupement de Coopération Sanitaire

Saint-Nazaire, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

CHU Rangueil

Toulouse, 31403, France

Location

Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Klinikum Leverkusen

Leverkusen, 51375, Germany

Location

Kardiologische Praxis und Praxisklinik

München, 81379, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Azienda Ospedale "S.G. Moscati"

Avellino, Italy

Location

Ospedale Civile di Legnano

Legnano, Italy

Location

Ospedale Carlo Poma

Mantova, Italy

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

Azienda Ospedaliero-Universitaria Pisana - MCV I°

Pisa, Italy

Location

Azienda Ospedaliera "Ordine Mauriziano di Torino"

Torino, Italy

Location

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

Treviso, Italy

Location

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands

Location

University Clinic of Cardiology

Skopje, North Macedonia

Location

Hospital General Yague

Burgos, Spain, 09005, Spain

Location

Hospital Infanta Cristina

Badajoz, 06005, Spain

Location

Hospital German Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Sant Pau i Sant Creu

Barcelona, 08025, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 028026, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, 030120, Spain

Location

Hospital Valdecilla

Santander, 039008, Spain

Location

Hospital del Mexoeiro

Vigo, 36200, Spain

Location

University Hospital Fribourg

Fribourg, Switzerland

Location

Royal Victoria Hospital

Belfast, United Kingdom

Location

Lancashire Cardiac Centre

Blackpool, United Kingdom

Location

Royal Sussex County Hospital

Brighton, United Kingdom

Location

St Thomas Hospital

London, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Location

Craigavon Cardiac Centre

Portadown, United Kingdom

Location

Royal Victoria Hospital

Wolverhampton, United Kingdom

Location

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Stenosis; Heart Diseases

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Vascular Diseases; Coronary Disease

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: April 27, 2011
• Study Start: October 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 13, 2012

Record last verified: 2012-03

Locations

CH (1); IT (7); NL (1); FR (19); NO (1); GB (7); DE (4); ES (10)