A Randomized Trial of Angioseal and Starclose for Hemostasis After PCI
试验速览
- 阶段
- 不适用
- 入组人数
- 448
- 试验地点
- 2
- 主要终点
- A composite of major vascular complications defined as device failure, bleeding, large hematoma, local infection etc.
研究概览
简要总结
PCI (coronary angioplasty) is a procedure performed through a catheter to open up blockages in the coronary arteries using balloons and stents for the treatment of angina or myocardial infarction. The balloon catheters and stents are moved to the coronary arteries through a "sheath" (a small tube used for placing of balloon and stent catheters in the body) placed in a major artery passing through the groin. After the PCI procedure and the removal of sheath, an "arterial closure device" is commonly placed to stop bleeding and allow you to get out of bed sooner. Although the usefulness of "closure devices" has been documented before their approval by the regulatory authorities, it is unclear if one device is better compared to other commercially available devices.
The purpose of the study is to compare the two approved arterial closure devices, "Angioseal" and "Starclose". This study will help us identify the better of the two devices to improve patient comfort after the procedure.
详细描述
All patients scheduled to undergo percutaneous coronary interventions will be screened for inclusion into the study. Informed consent will be obtained and patients will be randomized to the placement of either Angioseal or a Starclose vascular closure device to achieve hemostasis after the PCI procedure. The randomization will take place after a femoral angiogram has confirmed the suitability of the femoral artery for placement of arterial closure device. All patients will be monitored for bleeding or hematoma formation for twelve hours after the procedure. Patients will be ambulated at two hours after placement of the arterial closure device. A complete blood count and a vascular ultrasound will be performed in all patients before discharge to assess blood loss and detect vascular complications such as hematoma, arteriovenous fistula or femoral artery pseudoaneurysm. A written quality of life survey will be completed before discharge and at four weeks. A nursing survey will be completed by the nursing staff to determine nurse-sensitive outcomes and nurse resource utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing non emergent PCI procedures with a 6F arterial sheath.
- •Femoral artery anatomy favorable for the placement of an arterial closure device.
排除标准
- •Emergency PCI
- •End stage renal disease
- •Prior arterial closure device use within 90 days.
- •Symptomatic peripheral vascular disease.
- •Arterial puncture of the superficial femoral artery.
- •Suspected double wall puncture (puncture of anterior & posterior wall of femoral artery).
- •Placement of intra aortic balloon pump.
- •Placement of a femoral venous sheath.
结局指标
主要结局
A composite of major vascular complications defined as device failure, bleeding, large hematoma, local infection etc.
次要结局
- Time to hemostasis
- Lack of ambulation per protocol
- Need for additional measures to achieve hemostasis (manual pressure, femostop use, etc.)
- Minor vascular complication (minor bleeding, analgesic use)
- post procedural myocardial infarction
- 30 day incidence of death, MI, TVR
- Patient discomfort
- Quality of life measurements at discharge and four weeks
- Nurse resource utilization at discharge