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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ischemic Heart Disease, Coronary Artery Stenosis

Intervention / Treatment
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* Device: Angioplasty (PROMUS Element™, and Xience™ Prime stent)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Inclusion Criteria 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). Angiographic Inclusion criteria: 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. Exclusion Criteria: 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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PROMUS Element™<br>All patients enrolled will be randomized 2:1 to receive the PROMUS Element™ stent (N=1987) | Device: Angioplasty (PROMUS Element™, and Xience™ Prime stent)<br>* 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.<br>|
| Xience™ Prime stent<br>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)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart disease, Coronary Revascularization