This is a prospective single arm study enrolling patients who are scheduled for creation of a new Brachiocephalic or Radiocephalic AV fistula. Up to 80 patients will be enrolled, 50 with upper arm AV fistula and 30 with forearm AV fistula. All patients will be implanted with the VasQ device, a subcutaneous arteriovenous conduit support for vascular access. The follow up period in this study will be for a duration of 12 months, with follow up visits scheduled at 1, 3, 6, 9, and 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.
Institut Mutualiste Montsouris
Paris, France
Universitätsklinikum Augsburg
Augsburg, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Königin Elisabeth Krankenhaus Herzberge
Berlin, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Germany
University Hospital Cologne
Cologne, Germany
Universitaetsklinikum Jena
Jena, Germany
Klinikum Ernst von Bergmann gemeinnützige GmbH
Potsdam, Germany
Harzklinikum Dorothea Christiane Erxleben
Wernigerode, Germany
Hospital Clinic of Barcelona
Barcelona, Spain
...and 1 more locations
Primary patency of AV fistula
Freedom from any intervention designed to maintain or reestablish patency since device placement and demonstrate flow on Doppler US. 1 = Success = Intervention free access patency determined by Doppler ultrasound. 0 = Failure = Access occluded determined by Doppler ultrasound and/or underwent intervention
Time frame: 6 months post AVF creation
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