Joint Inflation With Nominal-pressure and Stability Approach in Coronary Drug-Eluting Stent Optimization and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Stent optimization
研究概览
简要总结
To achieve the stent optimization following "Keep It Simple and Safe" coronary intervention is recommended. A protocol of Joint Inflation with Nominal-pressure and Stability (JINS) approach in coronary drug-eluting stent (DES) implantation by intracoronary imaging (ICI) guidance could provide additional benefits in reducing unnecessary radiation exposure, and post-dilatation balloon angioplasty-related complications.
详细描述
Variable types of stent inflation protocol to achieve evidence and consensus-based coronary drug-eluting stent (DES) optimization could improve clinical outcomes. The investigators aim to evaluate whether the JINS approach could be adopted in Chinese daily practice.
The investigators will perform ICI (OCT or IVUS)-guided DES implantation in coronary de novo lesions by JINS protocol, described as inflating stent balloon with nominal-pressure (+1~2atm) without decay for at least 30 seconds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute coronary syndrome (UA/NSTEMI/STEMI) plan to undergo OCT- or IVUS-guided DES implantation in de novo lesion.
- •Patients provide written informed consent prior to enrollment.
排除标准
- •Left main, ostial right coronary artery lesion.
- •High thrombus burden at the index primary percutaneous coronary intervention.
- •Active bleeding or bleeding diathesis, thrombocytopenia (platelet <100,000/mL), or hemoglobin <10 g/dL
- •Hepatic dysfunction (serum liver enzyme>3 times the normal limit)
- •Renal failure (eGFR <15 ml/min/1.73m2 or requiring dialysis)
- •Life expectancy < 1 year
研究组 & 干预措施
JINS approach
The JINS approach is described as inflating a stent balloon with nominal-pressure without decay for at least 30 seconds.
干预措施: ICI-guided JINS approach (Procedure)
结局指标
主要结局
Stent optimization
时间窗: At 24 hours
To achieve the targets as follow: minimal stent area (MSA) \>5.5 mm2 by IVUS or MSA \>4.5mm2 by OCT, stent expansion \>80% (MSA divided by average reference lumen area), no significant malapposition, no significant stent edge dissection, no significant tissue protrusion, and successful DES implantation without the occurrence of cardiac death, target vessel myocardial infarction, target lesion revascularization, acute stent thrombosis during the first 24 hours after an index procedure.
次要结局
- Target vessel failure(At 12 months)
研究者
Cai De Jin, MD
Principal Investigator
Zunyi Medical College