NCT01896401终止不适用
InSeal Vascular Closure Device Clinical Study Protocol
InSeal Medical Ltd.2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- 1. Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 second
研究概览
简要总结
The InSeal vascular closure device (VCD)is assessed as percutaneous closure of artery access sites for quick hemostasis and ambulation in patients who have undergone large bore endovascular catheterization procedures.
The study hypothesis is that the VCD is safe and efficaient in achieving hemostasis in the study population.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidate for large bore catheterization procedure (such as TAVI, aortic endograft repair) using a CE approved 18Fr access sheath.
- •Subject age is at least 18 years
- •Patient has signed most recent approved version of the Informed Consent
- •Existence of an additional arterial access port is required in instances where an occluding balloon is planned to be used as a safety precaution.
排除标准
- •Women Of Child Bearing Potential (WOCBP)
- •Legally non-competent patients
- •Patient participating in another clinical study at the time of the InSeal VCD study
- •Prior target artery closure with a vascular closure device having intravascular component (such as Angio-Seal) 30 days prior to catheterization
- •Subjects with known coagulopathy, preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to artery closure
- •Patients that do not tolerate aspirin and clopidogrel anticoagulation treatment
- •Prior vascular surgery or vascular graft in region of access site
- •Significant calcification, atherosclerotic disease, or stent within 1.5 cm of the puncture site that may interfere with the operation of the experimental device
结局指标
主要结局
1. Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 second
时间窗: 15 minutes
次要结局
- 2. Combined rate of closure-device related major adverse events in first month(1 month)
研究者
研究点 (2)
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