Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
122 participants
OBSERVATIONAL
2023-06-02
2024-09-27
Brief Summary
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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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Conditions
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Keywords
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Study Design
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CASE_ONLY
OTHER
Study Groups
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BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System
Subject implanted with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.
BIOTRONIK 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.
Interventions
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BIOTRONIK 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.
Eligibility Criteria
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Inclusion Criteria
* 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 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 .
18 Years
ALL
No
Sponsors
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Biotronik AG
INDUSTRY
Biotronik (Beijing) Medical Device Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Wei Yang
Role: PRINCIPAL_INVESTIGATOR
The Fourth Affiliated Hospital of Harbin Medical University
Locations
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The 4th Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Zhejiang University Mingzhou Hospital
Ningbo, Zhejiang, China
Countries
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References
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Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Ronden J, Bressers M, Gobbens P, Negoita M, van Leeuwen F, Windecker S. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010 Jul 8;363(2):136-46. doi: 10.1056/NEJMoa1004130. Epub 2010 Jun 16.
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Tsuchida K, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher AM, Grube E, Haase J, Thuesen L, Hamm CW, Veldhof S, Dorange C, Serruys PW. One-year results of a durable polymer everolimus-eluting stent in de novo coronary narrowings (The SPIRIT FIRST Trial). EuroIntervention. 2005 Nov;1(3):266-72.
Serruys PW, Ong AT, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher A, Grube E, Haase J, Thuesen L, Hamm C, Otto-Terlouw PC. A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: The SPIRIT first trial. EuroIntervention. 2005 May;1(1):58-65.
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Suzuki T, Kopia G, Hayashi S, Bailey LR, Llanos G, Wilensky R, Klugherz BD, Papandreou G, Narayan P, Leon MB, Yeung AC, Tio F, Tsao PS, Falotico R, Carter AJ. Stent-based delivery of sirolimus reduces neointimal formation in a porcine coronary model. Circulation. 2001 Sep 4;104(10):1188-93. doi: 10.1161/hc3601.093987.
Sousa JE, Costa MA, Farb A, Abizaid A, Sousa A, Seixas AC, da Silva LM, Feres F, Pinto I, Mattos LA, Virmani R. Images in cardiovascular medicine. Vascular healing 4 years after the implantation of sirolimus-eluting stent in humans: a histopathological examination. Circulation. 2004 Jul 6;110(1):e5-6. doi: 10.1161/01.CIR.0000134307.00204.B3. No abstract available.
Other Identifiers
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C2022
Identifier Type: -
Identifier Source: org_study_id