NCT01939249

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

BIOTRONIK-A Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects With up to Two de Novo Coronary Artery Lesions - IV

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 585 (estimated)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Abbott Laboratories Xience
DEVICE	Biotronik Orsiro

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-03-23
• Completion: 2020-01-01
• First posted: 2013-09-11
• Last updated: 2017-06-26

Locations

45 sites across 12 countries: Australia, Belgium, Denmark, Germany, Israel, Japan, Netherlands, New Zealand, Poland, Spain, Sweden, Switzerland