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Study of the Orsiro Drug Eluting Stent System

NCT01356888 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2018-05-31

No results posted yet for this study

Summary

The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months.

Conditions

Interventions

DEVICE

Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)

Stenting

DEVICE

Percutaneous Coronary Intervention (Orsiro DES)

stenting

Sponsors & Collaborators

  • Biotronik AG

    lead INDUSTRY

Principal Investigators

  • Stephan Windecker, MD · University Hospital (Inselspital) / Bern / Switzerland

  • Thierry Lefèvre, MD · Institute Hospitalier Jaques Cartier / Massy / France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-07-31
Completion
2018-12-31

Countries

  • Austria
  • France
  • Germany
  • Hungary
  • Latvia
  • Netherlands
  • Spain
  • Switzerland

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 NCT01356888 on ClinicalTrials.gov