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NCT05667285
BIOFLOW-china Post-marketing Study (BIOTRONIK)
Conditions: In-Stent Stenosis (Restenosis) of Coronary Artery Stent, Native Coronary Artery Stenosis
Sex: All
Ages: 18 Years – N/A
Enrollment: 2000
Sponsor: Biotronik (Beijing) Medical Device Ltd.
Location: China
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05667285). StuddyBuddy aggregates publicly available trial information.