NCT05667285

BIOFLOW-china Post-marketing Study (BIOTRONIK)

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 122 (actual)
• Sponsor: Biotronik (Beijing) Medical Device Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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-up after 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.

Conditions

• In-Stent Stenosis (Restenosis) of Coronary Artery Stent
• Native Coronary Artery Stenosis

Interventions

Type	Name	Description
DEVICE	BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System	During the procedure, the investigator assesses the arterial diameter and lesion length either visually or using QCA to select the appropriate stent. The number of stents required for each lesion is determined by the investigator based on the specific circumstances. The length of the stent should cover from the proximal normal reference vessel to the distal normal reference vessel, ensuring complete coverage of the lesion. The number of stents required for each lesion is determined by the investigator based on the specific circumstances. If the first stent does not fully cover the lesion, a second or even more stents may be used. In such cases, the second or additional stents are selected by the investigator based on the specific circumstances, such as using Orsiro SES stents, unless clinically contraindicated or specifically required. Please refer to the stent's Instructions for Use for the procedure. If stent overlap occurs, the overlapping part should be at least 2mm.

Timeline

• Start date: 2023-06-02
• Primary completion: 2024-09-27
• Completion: 2024-09-27
• First posted: 2022-12-28
• Last updated: 2024-12-16

Locations

2 sites across 1 country: China