MedTrace Logo

PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study

NCT01148329 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1010

Last updated 2017-02-02

No results posted yet for this study

Summary

The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.

Conditions

Interventions

DEVICE

Coronary stenting

The PROMUS™ Element™ Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm, 28 mm, 32 mm, 38mm) with a reference vessel diameter of 2.25 mm - 4.0 mm.

Sponsors & Collaborators

  • Pharmaceutical Research Associates

    collaborator OTHER

  • Medidata Solutions

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Raul Moreno, MD PhD · Hospital La Paz, Spain

  • Peter Maurer, PhD · Boston Scientific Corporation

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-06-30
Completion
2016-12-31

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01148329 on ClinicalTrials.gov