BIOFLOW-china Post-marketing Study (BIOTRONIK)

Native Coronary Artery Stenosis Clinical Trial

Official title: Chinese Post-marketing Clinical Study Project Protocol for Evaluate the Safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System

Status Enrolling by invitation

Clinical Trial Summary

This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods.

The goal of this study is to assess the safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in the Chinese patient population after marketing in China.

Clinical Trial Description

This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods. A total of 2,000 subjects will be enrolled from up to 15 research sites in China. Suitable subjects will be selected according to the inclusion and exclusion criteria, and those who meet the inclusion and exclusion criteria will accept follow-upafter signing the informed consent form from the site ethics committee until 5 years after surgery. It is aimed to further assess the safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in the Chinese patient population after marketing in China by observing the data collected in this trial. ;

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Stenosis
• Native Coronary Artery Stenosis

• NCT number: NCT05667285
• Study type: Observational
• Source: Biotronik (Beijing) Medical Device Ltd.
• Status: Enrolling by invitation
• Start date: May 26, 2023
• Completion date: December 31, 2029