Academic Journal
Angiographic and clinical comparison of novel Orsiro Hybrid sirolimus-eluting stents and Resolute Integrity zotarolimus-eluting stents in all-comers with coronary artery disease (ORIENT trial): study protocol for a randomized controlled trial
| العنوان: | Angiographic and clinical comparison of novel Orsiro Hybrid sirolimus-eluting stents and Resolute Integrity zotarolimus-eluting stents in all-comers with coronary artery disease (ORIENT trial): study protocol for a randomized controlled trial |
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| المؤلفون: | Lee, Joo Myung, Park, Sang-Don, Lim, Sang Yup, Doh, Joon-Hyung, Cho, Jin Man, Kim, Ki-Seok, Bae, Jang-Whan, Chung, Woo-Young, Youn, Tae-Jin |
| المساهمون: | 이주명, 박상돈, 임상엽, 도준형, 조진만, 김기석, 배장완, 정우영, 연태진 |
| بيانات النشر: | BioMed Central Ltd |
| سنة النشر: | 2013 |
| المجموعة: | Seoul National University: S-Space |
| مصطلحات موضوعية: | Drug-eluting stent, Orsiro hybrid stent, Zotarolimus-eluting stent, Coronary heart disease |
| الوصف: | Trial registration : Clinicaltrials.gov NCT01826552 ; Background : The Orsiro Hybrid sirolimus-eluting stent is a newly developed third-generation drug-eluting stent, featuring a unique dual-polymer mix. An active bioabsorbable polymer delivers the anti-proliferative drug, sirolimus, via controlled release, while a passive biocompatible polymeric coating shields the metallic strut from surrounding tissue, preventing interaction. To date, the Orsiro Hybrid sirolimus-eluting stent has excelled in terms of late lumen loss at 9 months in a first-in-man single-arm trial. However, the efficacy and safety data for Orsiro Hybrid sirolimus-eluting stents in a broader population of all-comers are limited. The present study offers an angiographic and clinical comparison of the Orsiro Hybrid sirolimus-eluting stent and the Resolute Integrity zotarolimus-eluting stent in the treatment of patients with coronary artery disease. Methods/design : The ORIENT trial is a multicenter, randomized, open-label, parallel-arm study designed to demonstrate the non-inferiority of the Orsiro Hybrid sirolimus-eluting stent relative to the Resolute Integrity zotarolimus-eluting stent. A total of 375 patients with a spectrum of coronary artery disease will undergo prospective, random assignment to a Orsiro Hybrid sirolimus-eluting stent or Resolute Integrity zotarolimus-eluting stent (2:1 ratio), for a primary endpoint of in-stent late lumen loss at 9 months by quantitative coronary angiography. Secondary 12-month clinical endpoints are death, target lesion revascularization, target vessel revascularization, myocardial infarction, stent thrombosis and target lesion failure (a composite of cardiac death, target lesion revascularization and target vessel-related myocardial infarction). Discussion : The ORIENT trial is the first study to date comparing the Orsiro Hybrid sirolimus-eluting stent with the Resolute Integrity zotarolimus-eluting stent for efficacy and safety in a population of all-comers with coronary artery disease. ; This study is ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1745-6215 |
| Relation: | Trials Vol.14, pp.1-6; http://hdl.handle.net/10371/91353 |
| DOI: | 10.1186/1745-6215-14-398 |
| الاتاحة: | http://hdl.handle.net/10371/91353 https://doi.org/10.1186/1745-6215-14-398 |
| Rights: | Joo Myung Lee et al.; licensee BioMed Central Ltd. |
| رقم الانضمام: | edsbas.8151FFF2 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 17456215 |
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| DOI: | 10.1186/1745-6215-14-398 |