Randomized Comparison of MynxGrip Vascular Closure Device and Manual Compression for Closure After Femoral Access Angiography. The Closure Devices Used in Every Day Practice Study, CLOSE-UP III Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 869
- 试验地点
- 2
- 主要终点
- Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE)
研究概览
简要总结
Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the incidence of adverse access site related events in-hospital, at 30 days and at 6 months.
详细描述
Prospective, randomized (1:1), controlled, non-blinded, single center study in 2000 patients comparing the MynxGrip (test device) and manuel compression (standard comparator). Safety and efficacy endpoints will be reported for in-hospital, 30 days and 6 months.
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
- •>18 year
- •Should be able to provide valid informed signed consent
- •CAG, possibly including intracoronary measurement (FFR) or intracoronary imaging (IVUS, optical coherence tomography (OCT), NIRS)
排除标准
- •Percutaneous coronary intervention (PCI) procedure and/or implantation of stents
- •ST-Elevations Myocardial Infarction (STEMI)
- •Multiple punctures
- •Active infection
- •Groin haematoma before the closure procedure
- •Known pseudoaneurysm or arteriovenous (AV) fistula in the ipsilateral groin
- •Cardiogenic shock
- •Prior peripheral arterial surgery in abdomen or lower extremities
- •Sheat size >7 F
- •Life expectancy less than one year
- •Possible pregnancy or positive pregnancy test or breastfeeding women
- •Simultaneous or planned subsequent femoral vein access
- •Allergy to any of the components in the closure material left in the groin
- •Puncture or closure with closure device at same site < 30 days
- •Puncture or closure with manuel compression at same site < 5 days
- •Patients with peripheral artery disease can be included at operators discretion except if heavy calcification is present at the access site, which at the operators discretion precludes insertion of the closure device
研究组 & 干预措施
Manuel compression
Conventional manual compression
干预措施: Manual compression (Other)
MynxGrip closure device
Closure device for femoral artery access closure
干预措施: MynxGrip (Device)
结局指标
主要结局
Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE)
时间窗: 30 days
This includes: Major bleeding and/or blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery of leg, definitely or possible can be related to the closure procedure, infection needing antibiotics.
次要结局
- Need for medical evaluation of possible closure procedure related symptom(s)(30 days)
- Need for new onset of manual compression(30 days)
- Pain and discomfort related to the closure procedure(Closure procedure and 30 days)
- Time to mobilization(participants will be followed for the duration of hospital stay, an expected average of 2 days)
- Bleedings according to the Bleeding Academic Research Consortium (BARC) definitions(1 hour and 30 days)
- Major bleeding and/or bleeding necessitation blood transfusion(30 days and 6 months)
- Pseudoaneurysm with indication for treatment(30 days and 6 months)
- Arteriovenous fistula(30 days and 6 months)
- Vasovagal reaction until 5 minutes after end of closure procedure(30 minutes)
- Time (min) to haemostasis(30 days)
- In-hospital large groin haematoma(Participants will be followed for the duration of hospital stay, an expected average of 2 days)
- Groin surgery and/or possible related vascular surgery(30 days and 6 months)
- Infection needing antibiotics(30 days and 6 months)
- Device failure(30 minutes)
研究者
Evald Hoej Christiansen
MD
Aarhus University Hospital Skejby