The effectiveness and safety of the RESTORE(R) drug-eluting balloon versus a drug-eluting stent for small coronary vessel disease: study protocol for a multi-center, randomized, controlled trial
Yi-Da TANG
Shu-Bin QIAO
Xi SU
Yun-Dai CHEN
Ze-Ning JIN
Hui CHEN
Biao XU
Xiang-Qing KONG
Wen-Yue PANG
Yong LIU
Zai-Xin YU
Xue LI
Hui LI
Yan-Yan ZHAO
Wei LI
Jian TIAN
Chang-Dong GUAN
Bo XU
Run-Lin GAO
the RESTORE SVD China Investigators
摘要：Objective Small coronary vessel disease (disease affecting coronary vessels with main branch diameters of≤ 2.75 mm) is a common and intractable problem in percutaneous coronary intervention (PCI).This study was designed to test the theory that the effectiveness and safety of drug-eluting balloons for the treatment of de novo lesions in small coronary vessels are non-inferior to those of drug-eluting stents.Methods We designed a prospective,multicenter,randomized,controlled clinical trial aiming to assess the effectiveness and safety of the RESTORE(R) (Cardionovum,Bonn,Germany) drug-eluting balloon (DEB) versus the RESOLUTE(R) (Medtronic,USA) drug-eluting stent (DES) in the treatment of small coronary vessel disease.This trial started in August 2016.A total of 230 patients with a reference vessel diameter (RVD) ≥ 2.25 mm and ≤ 2.75 mm were randomly assigned to treatment with a DEB or a DES at a 1:1 ratio.The study was also designed to enroll 30 patients with an RVD ≥ 2.00 mm and ≤ 2.25 mm in the tiny vessel cohort.Results The key baseline data include demographic characteristics,relative medical history,baseline angiographic values and baseline procedural characteristics.The primary endpoint is in-segment diameter stenosis at nine months after the index procedure.Secondary endpoints include acute success,all-cause death,myocardial infarction,target vessel revascularization,target lesion revascularization and stent thrombosis.Conclusions The study will evaluate the clinical efficacy,angiographic outcomes,and safety of DEBs compared to DESs in the treatment of de novo coronary artery lesions in small vessels.
机标关键词：
论文发表日期：2018-07-19
在线出版日期：2025-08-15（本平台首次上网日期，不代表文献的发表时间）
页数：7( 469-475 )
英文信息