"TransRadial Ultra Support Technique" (TRUST Technique) Versus Anchoring Technique to Enhance Guiding Catheter Support: a Prospective Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Procedural success
研究概览
简要总结
Adequate support is required for challenging percutaneous coronary interventions (PCI). The "TransRadial Ultra Support Technique" (TRUST technique) is a new support technique that provides active support by deep pass of the coronary wire into the heart cavities (left ventricle-LV, right ventricle-RV) or aorta.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects singed informed consent form
- •Subjects eligible for percutaneous coronary intervention
排除标准
- •Age <18 years or >75 years
- •Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm
- •Known non-adherence to double anti-platelet therapy (DAPT)
- •LVEF <30%
- •Continuing bleeding
- •Acute coronary syndrome (ST-elevation Myocardial infarction)
- •Pregnancy
研究组 & 干预措施
TRUST technique + Coronary Stenting
PCI with coronary stenting using TransRadial Ultra Support technique for support improvement
干预措施: TRUST technique (Procedure)
TRUST technique + Coronary Stenting
PCI with coronary stenting using TransRadial Ultra Support technique for support improvement
干预措施: Coronary stenting (Procedure)
Anchoring technique + Coronary Stenting
PCI with coronary stenting using Wire Anchoring Pass technique for support improvement
干预措施: Anchoring Technique (Procedure)
Anchoring technique + Coronary Stenting
PCI with coronary stenting using Wire Anchoring Pass technique for support improvement
干预措施: Coronary stenting (Procedure)
结局指标
主要结局
Procedural success
时间窗: 1 week after PCI
Device success without the occurrence of in-hospital MACCE
Device success
时间窗: Intraoperative
Achievement of a final residual diameter stenosis \<20% and a TIMI 3 flow in the target vessel
次要结局
未报告次要终点