NCT01001663已完成4 期
Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography: the CLOSE-UP I Randomized Trial
Aarhus University Hospital Skejby2 个研究点 分布在 1 个国家目标入组 1,005 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,005
- 试验地点
- 2
- 主要终点
- Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm.
研究概览
简要总结
Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?
详细描述
Access site complication after coronary angiography is still a challenge in everyday practice. The FemoSeal® closure device has proven very safe as shown in the swedish SCAAR registry. This study is aimed to investigate, in a randomized design, if the FemoSeal® has an advantage in safety and efficacy over manual compression.
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
- •The patient must be at least 18 years old
- •Patients undergoing femoral access coronary angiography
- •Patient must be competent for providing informed, written consent
- •Only 6F sheath
排除标准
- •Percutaneous coronary intervention
- •Intra coronary measurements (FFR, IVUS, OCT, NIR)
- •Groin hematoma before closure
- •Pseudoaneurysm or AV fistula
- •Significant stenosis of ilial or femoral artery
- •Prior peripheral artery surgery
- •INR > 3,0
- •Platelet count < 120 million per millilitre blood
- •Coagulopathy (bleeding disorder)
- •Thrombolysis in the last 24h
- •Planned heparin infusion after the procedure
- •Pregnancy
- •Uncontrolled hypertension > 200 mmHg / 110 mmHg
- •Femoral access device closure in the last 30 days
结局指标
主要结局
Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm.
时间窗: 20 minutes, 1 hour and at discharge, pooled
次要结局
- Need for repeated manual compression after end of the closure procedure(14 days)
- Pain and discomfort measured on a numerical pain rating scale (0-10)(14 days)
- Vasovagal reaction (clinical signs AND Systolic BP drop of more than 30 mmHg AND/OR pulse drop more than 30 b/min. AND reversible immediately after treatment by atropin, fluids)(20 minutes)
- The patient seeking medical assistance for all-cause closure site related symptoms after discharge.(14 days)
- Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. Patient self-measurements.(14 days)
- Composite of: major vascular complications necessitating surgical repair, A-V fistulation, pseudoaneurysm needing treatment, major bleeding needing transfusion and infection needing antibiotics .(14 days)
- Time to hemostasis, from sheath removal to hemostasis is achieved(14 days)
- Time from end of closure procedure to ambulation. 1h bedrest recommended.(14 days)
- Device deployment failure(20 minutes)
- Time to cessation of continuous minor oozing measured from the end of the closure procedure(14 days)
研究者
Evald Hoej Christiansen
MD
Aarhus University Hospital Skejby
研究点 (2)
Loading locations...
相似试验
终止
不适用
AGIR Study: Angio-Seal in Interventional RadiologyVascular Access ComplicationNCT01911403Abbott Medical Devices123
已完成
不适用
STEP: Proglide® Versus Femoseal®: A Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial ProceduresPeripheral Arterial DiseaseNCT03192033Nantes University Hospital233
Unknown
不适用
Characteristics Predictive of Success and Complications in the Use of Suture-Mediated Closure of Femoral Venous AccessCardiac CatheterizationNCT00838175Brigham and Women's Hospital250
Unknown
不适用
Application of Vascular Closure Device in Transvenous Cardiac InterventionVascular Access ComplicationsNCT05521100Shanghai 10th People's Hospital160
已完成
不适用
Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions StudyArterial Closure DevicePercutaneous Coronary Intervention (PCI)Access Site BleedingAdverse Cardiac EventsNCT02455661Universitätsmedizin Mannheim600