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Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Park, Sang-Don | - |
dc.contributor.author | Yoon, Chang-Hwan | - |
dc.contributor.author | Oh, Il-Young | - |
dc.contributor.author | Suh, Jung-Won | - |
dc.contributor.author | Cho, Young-Suk | - |
dc.contributor.author | Youn, Tae-Jin | - |
dc.contributor.author | Choi, Dong-Ju | - |
dc.contributor.author | Chae, In-Ho | - |
dc.date.accessioned | 2013-05-29T05:35:51Z | - |
dc.date.available | 2013-05-29T05:35:51Z | - |
dc.date.issued | 2013-02-08 | - |
dc.identifier.citation | Trials, vol.14 no.38 | ko_KR |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | http://www.trialsjournal.com/content/14/1/38 | - |
dc.identifier.uri | https://hdl.handle.net/10371/82527 | - |
dc.description.abstract | Background : The use of a drug-eluting balloon for the treatment of de novo coronary artery lesions remains to be evaluated. A previous trial in patients with stable and unstable angina comparing a bare metal stent mounted on a drug-eluting balloon with a sirolimus-eluting stent failed to meet the prespecified non-inferiority criteria versus the sirolimus-eluting stent. The stent struts of a bare metal stent pre-mounted on a drug-eluting balloon may prevent the appropriate delivery of drugs to the vessel wall and may result in reduced efficacy. In the present study we will therefore evaluate the efficacy of a drug-eluting balloon for treating de novo coronary artery lesions using a strategy designed to uniformly deliver drug to the vessel with a bare metal stent.
Methods/Design : The Comparison of Drug-Eluting Balloon first study is a prospective, randomized, open-label trial designed to demonstrate the non-inferiority of first using a drug-eluting balloon (Sequent® please; B. Braun, Melsungen, Germany) followed by a bare metal stent (Coroflex® Blue; B. Braun) compared with using a drug-eluting stent (Resolute Integrity™; Boston Scientific, Natick, MA, USA) for de novo coronary artery lesions. The primary endpoint of the study is in-segment late loss at 9 months measured by quantitative coronary angiography. Secondary endpoints include angiographic findings such as angiographic success, device success, binary angiographic restenosis, and clinical outcomes such as procedural success, all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. A total of 180 patients will be enrolled in the study. Discussion : The Comparison of Drug-Eluting Balloon first study will evaluate the clinical efficacy, angiographic outcomes and safety of a drug-eluting balloon first followed by a bare metal stent compared with a drug-eluting stent for the treatment of de novo coronary artery lesions. | ko_KR |
dc.language.iso | en | ko_KR |
dc.publisher | BioMed Central | - |
dc.subject | Drug-eluting balloon | ko_KR |
dc.subject | Bare metal stent | ko_KR |
dc.subject | Drug-eluting stent | ko_KR |
dc.subject | In-segment late loss | ko_KR |
dc.title | Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial | ko_KR |
dc.type | Article | ko_KR |
dc.contributor.AlternativeAuthor | 박상돈 | - |
dc.contributor.AlternativeAuthor | 윤창환 | - |
dc.contributor.AlternativeAuthor | 오일영 | - |
dc.contributor.AlternativeAuthor | 서정원 | - |
dc.contributor.AlternativeAuthor | 조영석 | - |
dc.contributor.AlternativeAuthor | 연태진 | - |
dc.contributor.AlternativeAuthor | 최동주 | - |
dc.contributor.AlternativeAuthor | 채인호 | - |
dc.identifier.doi | 10.1186/1745-6215-14-38 | - |
dc.language.rfc3066 | en | - |
dc.description.version | Peer Reviewed | - |
dc.rights.holder | Sang-Don Park et al.; licensee BioMed Central Ltd. | - |
dc.date.updated | 2013-04-29T05:57:51Z | - |
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