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According to the renewal registration certificate requirements issued by the NMPA, this product does not need to collect post-market safety data.
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| Name | Class |
|---|---|
| Biotronik AG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System | Subject implanted with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The Sirolimus-eluting coronary stent system can improve the diameter of the coronary lumen. It is suitable for patients with ischemic heart disease symptoms caused by primary stenotic lesions and in-stent restenotic lesions (length ≤ 36 mm) dispersed within the native coronary arteries (reference vessel diameter of 2.25 mm to 4.0 mm).
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| Name | Affiliation | Role |
|---|---|---|
| Wei Yang | The Fourth Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 4th Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China | ||
| Zhejiang University Mingzhou Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32268942 | Background | Li C, Yang Y, Han Y, Song D, Xu J, Guan C, Gao R, Garcia-Garcia HM, Waksman R, Xu B; BIOFLOW VI Trial Investigators. Comparison of the Ultrathin Strut, Biodegradable Polymer Sirolimus-eluting Stent With a Durable Polymer Everolimus-eluting Stent in a Chinese Population: The Randomized BIOFLOW VI Trial. Clin Ther. 2020 Apr;42(4):649-660.e9. doi: 10.1016/j.clinthera.2020.02.014. Epub 2020 Apr 5. | |
| 32499026 |
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The sponsor has exclusive ownership of the trial data and results. During the clinical trial process, the sponsor has the right to consult and use all the data and results obtained from the trial. Before the results of each site are published and/or reported, any single clinical trial site is not allowed to publish and/or report its results. The sponsor agrees that the principal investigator of the trial may publish the results of the clinical trial.
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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 |
| Ningbo |
| Zhejiang |
| 310000 |
| China |
| Background |
| Kandzari DE, Koolen JJ, Doros G, Garcia-Garcia HM, Bennett J, Roguin A, Gharib EG, Cutlip DE, Waksman R; BIOFLOW V Investigators. Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization: 3-Year Outcomes From the Randomized BIOFLOW V Trial. JACC Cardiovasc Interv. 2020 Jun 8;13(11):1343-1353. doi: 10.1016/j.jcin.2020.02.019. |
| 31235458 | Background | Saito S, Toelg R, Witzenbichler B, Haude M, Masotti M, Salmeron R, Witkowski A, Uematsu M, Takahashi A, Waksman R, Slagboom T. BIOFLOW-IV, a randomised, intercontinental, multicentre study to assess the safety and effectiveness of the Orsiro sirolimus-eluting stent in the treatment of subjects with de novo coronary artery lesions: primary outcome target vessel failure at 12 months. EuroIntervention. 2019 Dec 6;15(11):e1006-e1013. doi: 10.4244/EIJ-D-18-01214. |
| 23339805 | Background | Hamon M, Niculescu R, Deleanu D, Dorobantu M, Weissman NJ, Waksman R. Clinical and angiographic experience with a third-generation drug-eluting Orsiro stent in the treatment of single de novo coronary artery lesions (BIOFLOW-I): a prospective, first-in-man study. EuroIntervention. 2013 Jan 22;8(9):1006-11. doi: 10.4244/EIJV8I9A155. |
| 20554978 | Background | 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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| 19758878 | Background | 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. |
| 11177716 | Background | Tsuji T, Tamai H, Igaki K, Kyo E, Kosuga K, Hata T, Okada M, Nakamura T, Komori H, Motohara S, Uehata H. Biodegradable Polymeric Stents. Curr Interv Cardiol Rep. 2001 Feb;3(1):10-17. |
| 18342684 | Background | Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008 Mar 15;371(9616):899-907. doi: 10.1016/S0140-6736(08)60415-8. |
| 19758877 | Background | Grube E, Hauptmann KE, Buellesfeld L, Lim V, Abizaid A. Six-month results of a randomized study to evaluate safety and efficacy of a Biolimus A9 eluting stent with a biodegradable polymer coating. EuroIntervention. 2005 May;1(1):53-7. |
| 19755281 | Background | Chevalier B, Serruys PW, Silber S, Garcia E, Suryapranata H, Hauptmann K, Wijns W, Schuler G, Fath-Ordoubadi F, Worthley S, Thuesen L, Meredith I, Bressers M, Nagai H, Paunovic D. Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus(R), paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the Nobori 1 trial. EuroIntervention. 2007 Feb;2(4):426-34. |
| 11249885 | Background | Carrie D, Khalife K, Citron B, Izaaz K, Hamon M, Juiliard JM, Leclercq F, Fourcade J, Lipiecki J, Sabatier R, Boulet V, Rinaldi JP, Mourali S, Fatouch M, El Mokhtar E, Aboujaoude G, Elbaz M, Grolleau R, Steg PG, Puel J; Benefit Evaluation of Direct Coronary Stenting Study Group. Comparison of direct coronary stenting with and without balloon predilatation in patients with stable angina pectoris. BET (Benefit Evaluation of Direct Coronary Stenting) Study Group. Am J Cardiol. 2001 Mar 15;87(6):693-8. doi: 10.1016/s0002-9149(00)01485-5. |
| 14562673 | Background | Unverdorben M, Sattler K, Degenhardt R, Fries R, Abt B, Wagner E, Koehler H, Scholz M, Ibrahim H, Tews KH, Hennen B, Daemgen G, Berthold HK, Vallbracht C. Comparison of a silicon carbide coated stent versus a noncoated stent in humans: the Tenax- versus Nir-Stent Study (TENISS). J Interv Cardiol. 2003 Aug;16(4):325-33. doi: 10.1034/j.1600-6143.2003.08058.x. |
| 12679775 | Background | Unverdorben M, Sippel B, Degenhardt R, Sattler K, Fries R, Abt B, Wagner E, Koehler H, Daemgen G, Scholz M, Ibrahim H, Tews KH, Hennen B, Berthold HK, Vallbracht C; Tenax versus Nir Stent Study. Comparison of a silicon carbide-coated stent versus a noncoated stent in human beings: the Tenax versus Nir Stent Study's long-term outcome. Am Heart J. 2003 Apr;145(4):e17. doi: 10.1067/mhj.2003.90. |
| 16784917 | Background | Schampaert E, Moses JW, Schofer J, Schluter M, Gershlick AH, Cohen EA, Palisaitis DA, Breithardt G, Donohoe DJ, Wang H, Popma JJ, Kuntz RE, Leon MB; SIRIUS, E- and C-SIRIUS Investigators. Sirolimus-eluting stents at two years: a pooled analysis of SIRIUS, E-SIRIUS, and C-SIRIUS with emphasis on late revascularizations and stent thromboses. Am J Cardiol. 2006 Jul 1;98(1):36-41. doi: 10.1016/j.amjcard.2006.01.049. Epub 2006 May 4. |
| 14550694 | Background | Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G; E-SIRIUS Investigators. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet. 2003 Oct 4;362(9390):1093-9. doi: 10.1016/S0140-6736(03)14462-5. |
| 19389558 | Background | Weisz G, Leon MB, Holmes DR Jr, Kereiakes DJ, Popma JJ, Teirstein PS, Cohen SA, Wang H, Cutlip DE, Moses JW. Five-year follow-up after sirolimus-eluting stent implantation results of the SIRIUS (Sirolimus-Eluting Stent in De-Novo Native Coronary Lesions) Trial. J Am Coll Cardiol. 2009 Apr 28;53(17):1488-97. doi: 10.1016/j.jacc.2009.01.050. |
| 16534015 | Background | Urban P, Gershlick AH, Guagliumi G, Guyon P, Lotan C, Schofer J, Seth A, Sousa JE, Wijns W, Berge C, Deme M, Stoll HP; e-Cypher Investigators. Safety of coronary sirolimus-eluting stents in daily clinical practice: one-year follow-up of the e-Cypher registry. Circulation. 2006 Mar 21;113(11):1434-41. doi: 10.1161/CIRCULATIONAHA.104.532242. Epub 2006 Mar 13. |
| 15028375 | Background | Schampaert E, Cohen EA, Schluter M, Reeves F, Traboulsi M, Title LM, Kuntz RE, Popma JJ; C-SIRIUS Investigators. The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). J Am Coll Cardiol. 2004 Mar 17;43(6):1110-5. doi: 10.1016/j.jacc.2004.01.024. |
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