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.
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 Type
OBSERVATIONAL
Enrollment
122
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.
The 4th Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Zhejiang University Mingzhou Hospital
Ningbo, Zhejiang, China
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).
Time frame: 1 years ± 60 days after surgery
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).
Time frame: 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).
Time frame: 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.
Time frame: 1, 2, 3, 4 and 5 years ± 60 days after surgery
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