NCT04555174

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 872 (actual)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Coronary Artery Disease
• Myocardial Ischemia

Interventions

Type	Name	Description
DEVICE	Orsiro Mission DES	Percutaneous Coronary Intervention (PCI)

Timeline

• Start date: 2020-09-25
• Primary completion: 2023-01-18
• Completion: 2027-02-19
• First posted: 2020-09-18
• Last updated: 2024-06-21

Locations

41 sites across 1 country: France