Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 818
- 试验地点
- 2
- 主要终点
- Incidence at 30 days of the composite endpoint of access site related major adverse vascular events (MAVE)
研究概览
简要总结
Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence of adverse access site related events at 30 days.
详细描述
Prospective, randomized (1:1) controlled, single blind, single center study in 2000 percutaneous coronary intervention (PCI) patients comparing the ExoSeal VCD (test device) to the AngioSeal VCD (standard comparator). In-hospital and 30 days safety and efficacy endpoints and 6 months safety endpoints will be reported.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Should be able to provide valid informed signed consent
- •PCI procedure including treatment by balloon and/or stent
- •PCI indicated by silent ischemia, stable angina pectoris, non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)
排除标准
- •Only coronary angiography
- •Multiple punctures
- •Active infection
- •Groin haematoma before the closure procedure
- •Sheath size > 7 French
- •Known pseudoaneurysm or arteriovenous (AV)-fistula in the ipsilateral groin
- •Prior arterial surgery in abdomen and/or lower extremities
- •Cardiogenic shock
- •Life expectancy less than one year
- •The patient is a female of childbearing potential with possible pregnancy or a positive pregnancy test within 7 days before the index procedure or is lactating
- •Simultaneous or planned subsequent femoral vein access
- •Allergy to any of the components in the closure material left in the groin
- •Puncture on same site < 30 days
- •Peripheral artery disease patients can be included at operator´s discretion except if heavy calcification is present at the access site which at the operator's discretion precludes insertion of the VCD
研究组 & 干预措施
Exoseal closure device
Closure device for femoral artery access closure
干预措施: Exoseal closure device (Device)
Angio-Seal closure device
Closure device for femoral artery access closure
干预措施: Angioseal closure device (Device)
结局指标
主要结局
Incidence at 30 days of the composite endpoint of access site related major adverse vascular events (MAVE)
时间窗: 30 days
This includes: major bleeding and/or bleeding necessitating blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery and/or possible related vascular surgery, infection needing antibiotics.
次要结局
- Device failure(30 minutes)
- Groin surgery and/or possible related vascular surgery(30 days and 6 months)
- Vasovagal reaction until 5 minutes after end of closure procedure(30 minuts)
- Pain and discomfort related to the closure procedure(Closure procedure and 30 days)
- Pseudoaneurysm with indication for treatment(30 days and 6 months)
- Arteriovenous fistula(30 days and 6 months)
- Bleedings according to the BARC definitions(30 days)
- Major bleeding and/or bleeding necessitating blood transfusion(6 months)
- Time to haemostasis from removing the sheath (AngioSeal) or inserting the device (ExoSeal) until haemostasis(participants will be followed for the duration of hospital stay, an expected average of 2 days)
- Need for new onset of manual compression(30 days)
- In-hospital large groin haematoma(participants will be followed for the duration of hospital stay, an expected average of 2 days)
- Infection needing antibiotics(30 days and 6 months)
- Time to mobilization(participants will be followed for the duration of hospital stay, an expected average of 2 days)
- Need for medical evaluation of possible closure procedure related symptom(s)(30 days)
研究者
Evald Hoej Christiansen
MD
Aarhus University Hospital Skejby