Randomized Controlled Trial for Comparison of Efficacy and Safety Between Drug-eluting Balloon and 2nd Generation Drug-Eluting Stent in Patients With In-Scaffold Restenosis of Bioresorbable Vascular Scaffold
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Minimum lumen diameter (MLD) in BRS ISR lesion, post-PCI
研究概览
简要总结
The aim of the study is to compare angiographic outcomes following revascularization using drug-eluting balloon (DEB) versus 2nd generation drug-eluting stent (DES) in treatment of Bioresorbable Vascular Scaffold Restenosis.
详细描述
The bioresorbable vascular scaffold (BRS) has been emerged as new therapeutic option in percutaneous coronary intervention for coronary artery disease. Although 2nd generation drug-eluting stent (DES) has enhanced the efficacy and safety of DES, However, along with the widespread use of this newer generation DES in most clinical conditions, including high-risk patients with more complicated lesion profiles, ISR has continued to be a major concern, even in the era of newer generation DES. In this regards, the concept of BRS has introduced and has showed promising results. Nevertheless, previous reports showed that even BRS has not been free from restenosis, leading target lesion revascularization up to 7.4% during 3-year follow up. Currently, previous researches which comparedsafety and efficacy of treatment options for ISR lesion showed similar clinical outcomes following 2 representative options, namely, drug-eluting balloon or drug-eluting stent. In this regards, current European Society of Cardiology/European Association for Cardiothoracic Surgery (ESC/EACTS) guidelines recommend drug-eluting balloon (DEB) and 2nd generation DES as class IA recommendations for the treatment of BMS or DES-ISR. However, all the previous reports evaluated the ISR of metallic stents, and there has been no evidence for treatment option for BRS ISR.
Therefore, the Smart Angioplasty Research Team: Safety and Efficacy of Drug-Eluting Balloon versus 2nd Generation Drug-Eluting Stent in Treatment of In-Bioresorbable Vascular Scaffold Restenosis (SMART-BRS-ISR) trial will randomly allocate patients with BRS ISR into DEB or 2nd generation DES and compare safety and efficacy of both treatment options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject age 19-85 years old
- •Patients with BRS ISR and presented with angina symptom or objective sign of inducible myocardial ischemia (one of the followings)
- •Visual stenosis ≥50% in ISR segment with typical angina symptom (CCS class ≥II) or positive non-invasive stress tests
- •ISR lesion with fractional flow reserve (FFR) ≤0.80
- •Visual stenosis ≥70% in ISR segment (in the absence of above 2 components)
- •Patients with BRS ISR which can be treated by DEB angioplasty or second generation DES implantation
排除标准
- •Cardiogenic shock (Killip class IV) already at presentation or the completion of culprit PCI
- •Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus, Zotarolimus
- •Patients with active bleeding or history of gastrointestinal or genitourinary major bleeding within 3-month
- •Chronic kidney disease (serum creatinine ≥2.0mg/dL or estimated glomerular filtration rate <30ml/min)
- •Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- •In-segment edge restenosis without definite involvement of previous BRS edge
- •Unwillingness or inability to comply with the procedures described in this protocol.
结局指标
主要结局
Minimum lumen diameter (MLD) in BRS ISR lesion, post-PCI
时间窗: 13-month after index procedure
次要结局
- minimum stent area measured by optical coherence tomography (OCT)(Immediate after index procedure)
- follow-up FFR(13-month after index procedure)
- post-PCI MLD(Immediate after index procedure)
- minimum stent area (MSA) measured by intravascular ultrasound (IVUS)(Immediate after index procedure)
- post-PCI FFR value(Immediate after index procedure)
- 13-month follow-up minimal stent area measured by IVUS or OCT(13-month after index procedure)
- Any myocardial infarction(12-month after index procedure)
- All-cause mortality(12-month after index procedure)
- Cardiac death(12-month after index procedure)
- Stent thrombosis(12-month after index procedure)
- OCT findings in neoatherosclerotic tissue(13-month after index procedure)
- Target vessel revascularization(12-month after index procedure)
- 12-month follow up any revascularization(12-month after index procedure)
- Major adverse cardiovascular events(12-month after index procedure)
研究者
Joo-Yong Hahn
Professor
Samsung Medical Center