NCT01342822

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,980 (estimated)
• Sponsor: European Cardiovascular Research Center · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Ischemic Heart Disease
• Coronary Artery Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2011-04-27
• Last updated: 2012-03-13

Locations

50 sites across 8 countries: France, Germany, Italy, Netherlands, North Macedonia, Spain, Switzerland, United Kingdom