This study will assess the safety and efficacy of a completely autologous and completely biological tissue engineered blood vessel (TEBV) called Lifeline™ used as an arteriovenous fistula for dialysis access.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Surgical arteriovenous fistula formation with the use of Lifeline blood vessel
Instituto Argentino de Diagnostico y Tratamiento
Buenos Aires, Argentina
Department of General, Vascular and Transplant Surgery
Katowice, Poland
The primary purpose of this study will be to gain preliminary safety experience with Lifeline blood vessel as an arteriovenous fistula
Time frame: minimum 3 months
The secondary purpose of the study is to assess the efficacy of the Lifeline blood vessel used as hemodialysis access in ESRD patients
Time frame: 36 months
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