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

Launched by EUROPEAN CARDIOVASCULAR RESEARCH CENTER · Apr 26, 2011

Keywords

ClinConnect Summary

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 p...

Gender

ALL

Eligibility 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. -