The QuickClose Study: Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose: a Prospective, Non-Randomized Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- rate of complication
研究概览
简要总结
The QuickClose study is a prospective, non-randomized study, to evaluate the safety and efficacy of the QuickClose device using two different dose types of heat exposure.
Patients undergoing a diagnostic angiogram procedure will be treated with the QuickClose device. Two groups of 20 patients each, will be enrolled consecutively, Group A will complete enrollment before enrollment into Group B begins. Patients will be monitored until 30 days after the procedure
详细描述
The primary safety endpoint is the incidence of major complications related to method for achieving hemostasis at the puncture site. The secondary safety endpoint is the incidence of minor complications related to method for achieving hemostasis at the puncture site. The primary efficacy endpoint are time to hemostasis, time to ambulation and time to discharge . The secondary efficacy endpoints are device and procedure success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •The patient must be ≥ 18 years of age
- •The patient or guardian must provide written informed consent
- •The patient must be willing to comply with follow-up requirements
- •The patient has no child bearing potential or has a negative pregnancy test within the previous 7 days.
- •Patient is eligible for same day discharge
- •Procedural Inclusion:
- •A intravascular procedure was preformed using 6 Fr introducer
- •The introducer sheath is located in the common femoral artery
排除标准
- •Manual compression has been preformed on the ipsilateral arterial site within the previous 6 weeks
- •Any closure device has been used on the ipsilateral arterial site within the previous 180 days
- •Any reentry of the ipsilateral site is planned within the next 6 weeks.
- •History of surgical repair of blood vessels of the ipsilateral arterial site
- •Significant bleeding diathesis or platelet dysfunction
- •Thrombocytopenia (Plt count ≤ 100,000)
- •Anemia (Hgb ≤ 10mg/dl and/or Hct ≤ 30mg/dl)
- •Has life expectancy of less than 1 year due to terminal illness
- •Currently being treated for an infection
- •Receiving GP 2b/3a inhibitors or requires warfarin therapy within the last 14 days.
- •INR results > 1.2 on day of procedure
- •Experienced a Myocardial infarction (CK-MB ≥ 2x upper limits of normal) within the previous 72 hours
- •Received thrombolytic within previous 72 hours
- •Patient is currently enrolled in an investigational device or drug study which endpoints have not been met.
- •Absent of pedal pulse
- •Pre-existing autoimmune disease (i.e., Lupus, Addison's Disease, Grave's Disease)
- •Has Body Mass Index(BMI) <20, or BMI >40
研究组 & 干预措施
2
干预措施: QuickClose device (Device)
结局指标
主要结局
rate of complication
时间窗: 30 days
次要结局
- time to hemostasis(30 days)