A prospective double-blinded randomized study on drug-eluting stent implantation into nitrate-induced maximally dilated vessels in patients with coronary artery disease

Trials

Study Protocol

Sung Woo Kwon¹  Seong-Huan Choi¹  Seong-Ill Woo¹  Sang-Don Park¹  Gwang-Seok Yoon¹ 

[1] Division of Cardiology, Department of Internal Medicine, Inha University College of Medicine, 27, Inhang-Ro, Jung-Gu, 22332, Incheon, Republic of Korea;

关键词: Drug-eluting stent;    Coronary artery disease;    Vasodilation;    Nitrates;    Randomized controlled trial;   

DOI  :  10.1186/s13063-023-07497-5

 received in 2022-03-09, accepted in 2023-07-06,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPercutaneous coronary intervention (PCI) has been developed using drug-eluting stents (DES); however, stent implantation is associated with concerns of stent thrombosis and target vessel revascularization (TVR). The stent diameter is a critical factor in TVR and clinical events. The nitrate administration in coronary angiography can dilate the reference vessel diameter, enabling accurate vessel size measurement and optimal stent implantation support. This study was designed to evaluate the effect of stent implantation in the maximally dilated coronary artery in patients with coronary artery disease (CAD).MethodsThis prospective double-blinded randomized (1:1) study is designed to compare the efficacy and safety between DES implantation into the nitrate-induced maximally dilated vessels and conventional DES implantation in patients with CAD. A total of 400 patients who underwent PCI with a sirolimus-eluting stent will be enrolled. The primary endpoint is the mean diameter of the deployed stents. Secondary endpoints include cardiac death, myocardial infarction, stent thrombosis, or ischemia-driven TVR 1 year after the procedure.DiscussionThis study will be the first randomized controlled trial to evaluate the effect of DES implantation on nitrate-induced maximally dilated vessels in patients with CAD.Trial registrationThe trial was registered on 18 June 2021 as Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels (ClinicalTrials.gov Identifier: NCT04931784).

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 1