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BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry — BIOFLOW-VIII  

Coronary Artery Disease Clinical Trial

Official title:
BIOTRONIK - SaFety and Performance Registry for an aLl-comers Subject Population With the Limus Eluting Orsiro Mission Stent System Within Daily Clinical Practice: BIOFLOW-VIII

Clinical Trial Summary

The BIOFLOW-VIII registry is a post-market clinical evaluation of the Orsiro Mission stent in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

Clinical Trial Description

BIOFLOW-VIII is a national, prospective, non-randomized, multi-center, open-label registry to confirm both, the acute performance as well as the mid- and long-term safety and clinical performance of the Orsiro Mission stent in an all-comers patient population within daily clinical practice. A total of 868 subjects will be enrolled at approximately 50 study sites in France. Clinical follow-ups will take place at 6, 12, 36 and 60 months post index-procedure. Follow-ups can be conducted by telephone. A subgroup analysis will evaluate the outcomes for patients treated ambulatory with same day discharge. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04555174
Study type Observational [Patient Registry]
Source Biotronik AG
Contact
Status Active, not recruiting
Phase
Start date September 25, 2020
Completion date February 19, 2027
View Details
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