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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by European Cardiovascular Research Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
European Cardiovascular Research Center
ClinicalTrials.gov Identifier:
NCT01342822
First received: April 25, 2011
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Ischemic Heart Disease
Coronary Artery Stenosis
Device: Angioplasty (PROMUS Element™, and Xience™ Prime stent)
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by European Cardiovascular Research Center:

Primary Outcome Measures:
  • Target Vessel failure (TVF) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Clinical endpoints [ Time Frame: 30 days, 12 months and 24 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 2980
Study Start Date: October 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
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).
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All comers, in the indications reimbursed in the participating countries

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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342822

  Show 50 Study Locations
Sponsors and Collaborators
European Cardiovascular Research Center
  More Information

No publications provided

Responsible Party: European Cardiovascular Research Center
ClinicalTrials.gov Identifier: NCT01342822     History of Changes
Other Study ID Numbers: BSI-01
Study First Received: April 25, 2011
Last Updated: March 12, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Ministry of Health
Italy: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by European Cardiovascular Research Center:
Heart disease
Coronary Revascularization

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Coronary Stenosis
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014