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Clinical Trials/DRKS00026706
DRKS00026706
Not yet recruiting
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 sites350 target enrollmentSeptember 21, 2021
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ConditionsI35.0I35Aortic (valve) stenosisNonrheumatic aortic valve disorders

Overview

Phase
未知
Intervention
Not specified
Conditions
I35.0
Sponsor
Medizinische Klinik III, Kardiologie Universitätsklinikum Frankfurt am Main, Goethe-Universität
Enrollment
350
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 21, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • •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)

Exclusion Criteria

  • •\- 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)

Outcomes

Primary Outcomes

Not specified

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