In-Stent Stenosis (Restenosis) of Coronary Artery Stent, Native Coronary Artery Stenosis
Conditions
Keywords
Orsiro, BIOTRONIK, China, Coronary Stent System
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.
Interventions
DEVICEBIOTRONIK 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.
Sponsors
Biotronik AG
Biotronik (Beijing) Medical Device Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
China
Outcome results
None listed