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临床试验/NCT03429634
NCT03429634已完成早期 1 期

Comparative Study of Balloon-Stent Kissing Technique Versus Jailed Wire Technique for the Interventional Treatment of Coronary Bifurcation Lesions

Dalian University1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
89
试验地点
1
主要终点
Perioperative major adverse cardiovascular (MACE) events (%)

研究概览

简要总结

To compare the immediate and long-term clinical outcomes between Balloon-Stent Kissing Technique (BSKT) and Jailed Wire Technique (JWT) for the interventional treatment of coronary bifurcation lesions.

详细描述

Coronary bifurcation lesions account for 15-20% of percutaneous coronary interventions (PCIs)[1-2]. They have lower success rate after operation, higher re-stricture ratio by radiography and frequent complications, which result in adverse clinical outcomes as compared to non-bifurcation lesions[3-5]. Secure and efficient treatment strategies for PCI and bifurcation lesions are research hotspots for cardiovascular surgeons. Single-side stand strategy (main-support implantation stand or side-support implantation stand when necessary) is currently preferred for bifurcation lesions[2,6]. However, as main-support implantation stand could lead to plaque transposition, bifurcation ridge excursion and side a sandwich, the side openings could become narrower or even blocked[7]. In 2011, our centre initiated the use of balloon-stent kissing technique (BSKT)[8] to protect the side branch, which has higher success rate after operation, lower block ratio of side branch and lower incidence of perioperative adverse events, which led to immediate clinical effect. This study compared BSKT versus Jailed Wire Technique (JWT) in the interventional treatment of coronary bifurcation lesions to further clarify BSKT's efficacy and advantages.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with CHD;
  • coronary arteriography revealed true bifurcation lesion

排除标准

  • severe carcified lesion;
  • left main lesion;
  • severe heart failure(NYHA grade 4)

研究组 & 干预措施

Balloon-Stent Kissing technique

Experimental

randomly, patients with bifurcation lesion treated by Balloon-Stent Kissing intervention technique in this group.For procedure,stent in main vessel and balloon protect of side branch,final kiss-balloon was performed.

干预措施: Balloon-Stent Kissing technique (Procedure)

Balloon-Stent Kissing technique

Experimental

randomly, patients with bifurcation lesion treated by Balloon-Stent Kissing intervention technique in this group.For procedure,stent in main vessel and balloon protect of side branch,final kiss-balloon was performed.

干预措施: Jailed Wire technique (Procedure)

Jailed Wire technique

Sham Comparator

randomly,patients with bifurcation lesion treated by Jailed Wire intervention technique in this group.For procedure,stent in main vessel and only wire protect of side branch.If need,post-stent rewire of branch,and balloon dilation of side branch was performed.

干预措施: Balloon-Stent Kissing technique (Procedure)

Jailed Wire technique

Sham Comparator

randomly,patients with bifurcation lesion treated by Jailed Wire intervention technique in this group.For procedure,stent in main vessel and only wire protect of side branch.If need,post-stent rewire of branch,and balloon dilation of side branch was performed.

干预措施: Jailed Wire technique (Procedure)

结局指标

主要结局

Perioperative major adverse cardiovascular (MACE) events (%)

时间窗: up to 72hr after PCI

total percent of cardiac death, perioperative myocardial infarction and target lesion revascularization

次要结局

  • long-term clinical outcomes(%)(post-PCI to mean 19 month follow up)

研究者

发起方
Dalian University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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