jRCT2052220108进行中（未招募）不适用
A Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Absorbable Topical Hemostatic Agent (MY-01) in Hemostasis at Femoral Artery Access Site Following Percutaneous Catheterization Protocol
Cordis Jaoan GK0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Patient is 20 years of age or older
- •(2) Patient has provided a written informed consent
- •(3) Patient is scheduled for endovascular intervention on a lesion in the coronary or peripheral artery with a catheter inserted through the common femoral artery (the index limb of this study will be either left or right)
- •(4) Patient is scheduled for 5F, 6F or 7F puncture in the common femoral artery
排除标准
- •(1) BMI > 40 kg/m2
- •(2) STsegment elevation myocardial infarction over 48 hours prior to catheterization
- •(3) Patient with diseases such as thrombocytopenia (< 100,000), von Willebrand's disease, symptoms of anemia (hemoglobin < 10 g/dL, hematocrit < 30%), and hemorrhagic disease
- •(4) Prior vascular surgery in the ipsilateral femoral artery
- •(5) Pre-existing systemic or groin infection
结局指标
主要结局
-
Device Success
次要结局
未报告次要终点
研究者
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