A first-in-man clinical evaluation of sirolimus and ascorbic acid-eluting stent systems: A multicenter, subject-blinded, randomized studyopen access
- Authors
- Lim, Young-Hyo; Youn, Ji Hyun; Hong, Soon-Jun; Ahn, Tae-Hoon; Yoon, Junghan; Park, Jun-Kyu; Kim, Hyo-Soo
- Issue Date
- Dec-2021
- Publisher
- Korean Society of Circulation
- Keywords
- Absorbable implants; Ascorbic acid; Coronary artery disease; Drug-eluting stents; Sirolimus
- Citation
- Korean Circulation Journal, v.51, no.12, pp.1001 - 1014
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- Korean Circulation Journal
- Volume
- 51
- Number
- 12
- Start Page
- 1001
- End Page
- 1014
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/140179
- DOI
- 10.4070/KCJ.2021.0161
- ISSN
- 1738-5520
- Abstract
- Background and Objectives: This clinical trial was conducted to evaluate the safety and efficacy of D+Storm™ drug-eluting stent (DES) and BioMatrix Flex™ DES. Methods: This study was a multicenter, subject-single-blind, randomized, and confirmed comparative clinical trial. According to the inclusion criteria, those diagnosed with stable angina, unstable angina, silent ischemia, or non-ST-segment myocardial infarction were selected among patients with coronary artery stenosis as subjects. Among the subjects with 50% stenosis on coronary angiography, the experiment was performed on those who had a lesion with reference vessel 2.5–4.0 mm in diameter and ≤40 mm in length. The primary endpoint was an in-segment late loss and the secondary endpoints were in-stent late lumen loss, stent malapposition, the incidence of mortality, myocardial infarction, reoperation, and stent thrombosis at 36 weeks. Results: 57 patients in the D+Storm™ DES group and 55 patients in the BioMatrix Flex™ DES group were enrolled in the study. Fifty-seven patients in the D+Storm™ DES group and Fifty-five patients in the BioMatrix Flex™ DES group were enrolled in the study. An average of in-segment late lumen loss was 0.08±0.13 mm in the D+Storm™ DES group and 0.14±0.32 mm in the BioMatrix Flex™ DES group with no significant difference between the 2 groups (p=0.879). In addition, there was no significant difference in adverse events between D+Storm™ DES and BioMatrix Flex™ DES. Conclusions: This study demonstrated the clinical effectiveness and safety of D+Storm™ DES implantation in patients with coronary artery disease over a 36-week follow-up period.
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