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

NCT01342822 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2980

Last updated 2012-03-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • European Cardiovascular Research Center

    lead NETWORK

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • France
  • Germany
  • Italy
  • Netherlands
  • North Macedonia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01342822 on ClinicalTrials.gov