Over the past two decades, stents implantation has developed as a standard treatment for coronary stenosis lesions. However, int-stent restenosis (ISR) was one of the main factors affecting the long-term efficacy of coronary artery interventional therapy, with the incidence of ISR after percutaneous coronary intervention ranging from 5% to 35%. At present, there are three main means for ISR: (1) simple balloon dilation; 2) intravascular radiotherapy; and (3) drug elution stent. But the results are still not ideal. Drug coated balloon (DCB) is a new method that may be used to treat ISR in recent years. In the PEPCAD II study, when dealing with ISR, the paclitaxel eluting balloon (PEB) SeQuent® Please significantly reduced the major adverse cardiovascular events (MACEs) compared to the paclitaxel eluting stent (PES) TAXUS Liberte. In ISR-I and ISR-II trial, it was found that compared with uncoated PTCA balloons, PEB could significantly inhibit endothelial hyperplasia and significantly reduce MACEs treating ISR. The purpose of this study was to assess the efficacy and safety of a Chinese-developed PEB in treatment of coronary ISR compared to SeQuent® Please PEB.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
Treatment of coronary in-stent re-stenosis with paclitaxel eluting PTCA balloon
Treatment of coronary in-stent re-stenosis with SeQuent® Please paclitaxel eluting balloon
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGRate of target lesion late lumen loss
Time frame: 9 months
Rate of interventional therapy success
Including rate of device success, rate of disease success and rate of clinical success
Time frame: 0-24 hours, 30 days, 6 months, 9 months, 12 months
Rate of target lesion restenosis
Time frame: 9 months
Device-oriented composite clinical cardiovascular outcomes
Cardiac death, target vessel-related myocardial infarction, symptoms-driven target lesion revascularization
Time frame: 30 days, 6 months, 9 months, 12 months
Patient-oriented composite clinical cardiovascular outcomes
All-cause mortality, all myocardial infarction, all revascularization
Time frame: 30 days, 6 months, 9 months, 12 months
Rate of ARC defined thrombosis events
All definite, probable and possible thrombosis in acute, subacute and late stage
Time frame: 0-24 hours, 30 days, 6 months, 9 months, 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.