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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: 2024年8月19日

适应症

试验速览

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•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)

•- 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)

发起方

Medizinische Klinik III, Kardiologie Universitätsklinikum Frankfurt am Main, Goethe-Universität