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临床试验/NCT02137486
NCT02137486已完成不适用

Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques

Taipei City Hospital1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2015年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
214
试验地点
1
主要终点
Percentage of Participants With Major Adverse Cardiac Events(MACE)

研究概览

简要总结

Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis. Their structural properties make angioplasty technique to increase the difficulty of implementation, but also increased the risks of the in-stent thrombosis and restenosis. Standard treatment of coronary bifurcation lesions remains controversial manner, especially when the side branch (SB) was large combined with high angulated bifurcation lesions. Complex procedures and certain types of lesions are associated with poor prognosis. There is no standard treatment for such lesions even with the development of drug-eluting stents solve partial problems. The investigators reviewed patients who received coronary intervention between 2009-2012 years and met the inclusion criteria, and then analyzed the prognostic relevance of these cases the use of different treatment modalities.

We introduced a retrospective analysis for high angulated bifurcation lesions treated with either DES or BMS.

Primary endpoint: cardiovascular mortality, TLR, MACE. secondary endpoint: procedure time, fluoroscopy time, procedure success, angiographic success.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Angulated bifurcation:MV(main branch) and SB(side branch) angle>70 degree. MV diameter≥2.5mm and eligible for stenting. lesion stenotic severity>70% by QCA(Quantitative coronary analysis). 1 stent strategy. SYNTAX>22 Procedure success. de novo lesion

排除标准

  • Bifurcation lesions intervention without side br. ballooning after stents deployment or procedure incomplete. Left main coronary artery bifurcational lesions. Elective,provisional or bail-out stenting for side br.

结局指标

主要结局

Percentage of Participants With Major Adverse Cardiac Events(MACE)

时间窗: periprocedure up to 12 months

Percentage of Participants with major adverse cardiac events(MACE) was defined as rates of target lesion revascularization (TLR) and restenosis during first post-treatment year, and rates of acute, subacute, and late in-stent thrombosis, periprocedure MI(myocardial infarction).

Percentage of Participants With Cardiovascular Mortality(%)

时间窗: periprocedure up to 12 months

Percentage of Participants with cardiovascular mortality was defined as death related to cardiovascular causes within 2 years.

次要结局

  • Percentage of Participants With Angiographic Success(%)(periprocedure up to 12 months.)
  • Fluoroscopy Time(Minutes) of Each Participants(periprocedure up to 12 months.)
  • Percentage of Participants With Target Vessel Revascularization Rate(periprocedure up to 12 months.)
  • Procedure Time(Minutes) of Each Participants(periprocedure up to 12 months.)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Yueh-Chung, Chen

chief of ICU

Taipei City Hospital

研究点 (1)

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