BIOFLOW-china Post-marketing Study (BIOTRONIK)

Terminated

• Conditions: In-Stent Stenosis (Restenosis) of Coronary Artery Stent; Native Coronary Artery Stenosis
• Interventions: Device: BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System

• Registration Number: NCT05667285
• Lead Sponsor: Biotronik (Beijing) Medical Device Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-26
• Study First Posted: 2022-12-28
• Study Start: 2023-06-02
• Primary Completion: 2024-09-27
• Study Completion: 2024-09-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• The subject should be 18 years or older when undergoing the procedure.
• The subject has signed the Informed Consent.
• The subject signed Informed Consent dated back within 12 months and was implanted with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.

Exclusion Criteria

• The subject has or had a life expectancy less then 12 month after treatment with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.
• The subject has any known allergies to the following substances: aspirin, heparin/divalerythromycin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), bivalirudin, rapamycin, L-605 cobalt-chromium (Co-Cr) alloy or its main elements (cobalt, chromium, tungsten and nickel), acrylic acid, fluoropolymer, silicon carbide, PLLA allergy or contraindications.
• The investigator judges that the subject has poor compliance and cannot complete the study as required, or other circumstances that are not suitable for participation in this study .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System	BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System	Subject only implanted with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.

Primary Outcome Measures

Name	Time	Method
Target lesion failure (TLF) at 1 years ± 60 days after surgery	1 years ± 60 days after surgery	Including cardiogenic death, target vessel Q-wave and non-Q-wave myocardial infarction, coronary artery bypass grafting (CABG), and clinically driven target lesion revascularization (TLR).

Secondary Outcome Measures

Name	Time	Method
Serious adverse device effects (SADEs)	1, 2, 3, 4 and 5 years ± 60 days after surgery	A serious adverse device effect (SADE) refers to any adverse device event that leads to the consequences and characteristics of serious adverse events.
Major adverse cardiac event (MACE) at 1, 2, 3, 4 and 5 years ± 60 days after surgery	1, 2, 3, 4 and 5 years ± 60 days after surgery	Including all-cause deaths, Q-wave or non-Q-wave myocardial infarction, and clinically driven target lesion revascularizition (TLR).
Target lesion failure (TLF) at 2, 3, 4 and 5 years ± 60 days after surgery	2, 3, 4 and 5 years ± 60 days after surgery	Including cardiogenic death, target vessel Q-wave and non-Q-wave myocardial infarction, coronary artery bypass grafting (CABG), and clinically driven target lesion revascularization (TLR).

Trial Locations

Locations (2)

The 4th Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Zhejiang University Mingzhou Hospital; 🇨🇳 Ningbo, Zhejiang, China