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| Name | Class |
|---|---|
| Meril Life Sciences Pvt. Ltd. | INDUSTRY |
| Terumo Corporation | INDUSTRY |
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Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with Xience® stent
A prospective, open, multicenter, and observational study will register and compare Xience® groups treated in institutions such as the BioMime ™, Ultimaster® group prospectively registered from June 2016.
The Xience® group has already been registered in the previous study (SMARTDESK-BX), so BioMimeTM and Ultimaster® only need to be registered. Follow-up will be conducted until December 2019, and e-CRF will be completed by April 2020.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioMimeTM Stent | No intervention / Ischemic heart disease with percutaneous coronary intervention with BioMimeTM Stent |
| |
| Ultimaster® Stent | No intervention / Ischemic heart disease with percutaneous coronary intervention with Ultimaster® stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioMimeTM Stent, Ultimaster® Stent | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of 1-year target lesion failure | The incidence of 1-year target lesion failure (combination of cardiac death, target vessel myocardial infarction, and target vessel revascularization). | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of 30-day and 2-year target lesion failure | 30-day and 2-year | |
| Incidence of 30-day, 1-year, and 2-year deaths | 30-day, 1-year, and 2-year | |
| Incidence of 30-day, 1-year, and 2-year cardiac events |
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Inclusion Criteria:
Exclusion Criteria:
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Ischemic heart disease with percutaneous coronary intervention with stenting
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyeon Cheol Gwon | Contact | hc.gwon@samsung.com | ||
| Taek Kyu Park | Contact | taekkyu.park@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Hyeon Cheol Gwon | Samsung Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18430909 | Background | Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903. | |
| 17145250 |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| C535731 | Dysequilibrium syndrome |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 30-day, 1-year, and 2-year |
| Incidence of 30-day, 1-year, and 2-year myocardial infarction | 30-day, 1-year, and 2-year |
| Incidence of 30-day, 1-year, and 2-year target vessel myocardial infarction | 30-day, 1-year, and 2-year |
| Incidence of 30-day, 1-year, and 2-year revascularization | 30-day, 1-year, and 2-year |
| Incidence of 30-day, 1-year, and 2-year target revascularization | 30-day, 1-year, and 2-year |
| Incidence of 30-day, 1-year, and 2-year stroke | 30-day, 1-year, and 2-year |
| Incidence of acute stent thrombosis at 24 hours, subacute stent thrombosis at 30 days, and stent thrombosis at 1 and 2 years | 24 hours, 30 days, 1 and 2 years |
| Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL. Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. Am J Med. 2006 Dec;119(12):1056-61. doi: 10.1016/j.amjmed.2006.01.023. |
| 17869634 | Background | Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5. |
| 26196753 | Background | Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vazquez N, Valdes M, Voudris V, Puricel S, Slagboom T, Goy JJ, den Heijer P, van der Ent M. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial. EuroIntervention. 2015 Jul;11(3):272-9. doi: 10.4244/EIJV11I3A53. |
| 26446596 | Background | Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Igarashi K, Tanabe K, Morino Y, Ishikawa T, Nishikawa H, Awata M, Abe M, Okada H, Takatsu Y, Ogata N, Kimura K, Urasawa K, Tarutani Y, Shiode N, Kimura T. Final 3-Year Outcome of a Randomized Trial Comparing Second-Generation Drug-Eluting Stents Using Either Biodegradable Polymer or Durable Polymer: NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial. Circ Cardiovasc Interv. 2015 Oct;8(10):e002817. doi: 10.1161/CIRCINTERVENTIONS.115.002817. |
| 24459196 | Background | Kang SH, Park KW, Kang DY, Lim WH, Park KT, Han JK, Kang HJ, Koo BK, Oh BH, Park YB, Kandzari DE, Cohen DJ, Hwang SS, Kim HS. Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis. Eur Heart J. 2014 May;35(17):1147-58. doi: 10.1093/eurheartj/eht570. Epub 2014 Jan 23. |