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Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent

NCT01939249 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 585

Last updated 2017-06-26

No results posted yet for this study

Summary

BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary lesions. The study is powered for non-inferiority with respect to Target Vessel Failure(TVF)at 12 months.

Conditions

Interventions

DEVICE

Abbott Laboratories Xience

DEVICE

Biotronik Orsiro

Sponsors & Collaborators

  • Biotronik AG

    lead INDUSTRY

Principal Investigators

  • Shigeru Saito, MD · Okinawa Tokushukai Shonan Kamakura General Hospital

  • Ton Slagboom, MD · Onze Lieve Vrouwe Gasthuis

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
2013-09-30
Primary Completion
2016-03-23
Completion
2020-01-31

Countries

  • Australia
  • Belgium
  • Denmark
  • Germany
  • Israel
  • Japan
  • Netherlands
  • New Zealand
  • Poland
  • Spain
  • Sweden
  • 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 NCT01939249 on ClinicalTrials.gov