DRKS00026706尚未招募未知
Comparison of a collagen-based and a suture-based vascular closure device for the occlusion of large-lumen arterial punctures during transfemoral TAVI procedures
Medizinische Klinik III, Kardiologie Universitätsklinikum Frankfurt am Main, Goethe-Universität0 个研究点目标入组 350 人开始时间: 2021年9月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •All patients> 18 years of age who receive an elective catheter-supported aortic valve replacement via a transfemoral access in the Medical Clinic III / Cardiology and / or the Clinic for Thoracic, Cardiac and Vascular Surgery at the University Hospital Frankfurt
- •- Inguinal / pelvic vessels suitable for the introduction of large-lumen vascular sluices up to 24F.
- •- Common femoral artery diameter> 6mm (compatible with 24F cannulas)
排除标准
- •- Patients <18 years of age
- •- Cardiogenic shock / clinically critical condition prior to intervention
- •- Symptomatic ischemia of the lower extremity
- •- Severe PAOD that requires a groin intervention (dilation / stent implantation) for the transfemoral percutaneous access
- •- s/p unilateral or bilateral amputation of the lower extremity
- •- Pregnancy (negative pregnancy test is mandatory for patients of childbearing age)
- •- Participation in another study with the primary endpoint vascular complications / bleeding
- •- Known allergies to components of both systems (e.g. bovine materials collagens, polyglycols, stainless steel, nickel)
- •- Contraindication for the expected safe use of one of the locking systems Manta® or Proglide® locking system (severe calcification, aneurysm, fistula)
研究者
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