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Erratum to: 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

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Authors
Park, Sang-Don; Yoon, Chang-Hwan; Oh, Il-Young; Suh, Jung-Won; Cho, Young-Suk; Youn, Tae-Jin; Choi, Dong-Ju; Chae, In-Ho
Issue Date
2017-05-23
Citation
Trials, 18(1):232
Keywords
Drug-eluting balloonBare metal stentDrug-eluting stentIn-segment late loss
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.
ISSN
1745-6215
Language
English
URI
https://doi.org/10.1186/s13063-017-1793-y

http://hdl.handle.net/10371/117660
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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