BIOFLOW-china Post-marketing Study (BIOTRONIK)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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In-Stent Stenosis (Restenosis) of Coronary Artery Stent, Native Coronary Artery Stenosis

Intervention / Treatment
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* Device: BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject should be 18 years or older when undergoing the procedure; Subjects sign informed consent; The subject signed informed consent dated back within 12 months and only 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 ; Has undergone PCI without a study stent implantation; 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System<br>Subject only implanted with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation. | Device: BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System<br>* The investigator will use visual inspection or QCA to assess the diameter of the artery and the length of the lesion during the operation to select the stent. For each lesion, the investigator will determine the number of stents to be used based on the actual situation. The length of the stent should cover from the proximal end of the normal reference vessel to the distal end of the normal reference vessel to ensure full coverage of the lesion. For each lesion, the investigator will determine the number of stents to be used based on the actual situation. A second stent or more stents can be used when the first stent does not completely cover the lesion. In this case, the second stent or even more stents must be this investigational stent, unless it is clinically contraindicated. Please refer to the IFU operating procedure of the stent. If the stents are placed overlappingly, the overlapping part should be at least 2 mm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure (TLF) at 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). | 1 years ± 60 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac event (MACE) at 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). | 1, 2, 3, 4 and 5 years ± 60 days after surgery | 
| Target lesion failure (TLF) at 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). | 2, 3, 4 and 5 years ± 60 days after surgery | 
| Serious adverse device effects (SADEs) | A serious adverse device effect (SADE) refers to any adverse device event that leads to the consequences and characteristics of serious adverse events. | 1, 2, 3, 4 and 5 years ± 60 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orsiro, BIOTRONIK, China, Coronary Stent System