Study of a novel implantable device to generate an autologous vascular graft for hemodialysis access - VACIS Rod

VACIS B.V.0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

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•For this study, we aim to include a total of 20 hemodialysis patients. Patients
•with a need for a arteriovenous access in whom only an AV graft can be
•considered or with a history of failed previous vascular access are considered
•to participate in this study. Patients are at least 18 and not older than 80
•years old. To be eligible to participate in this study, a subject must meet the
•following inclusion criteria:
•The patient:
•1) is in need of hemodialysis according to the treating nephrologist
•2) has a suitable location for an AV graft, preferably in the upper arm or
•3) is considered eligible for arteriovenous access surgery
•4) has no suitable autologous options
•5) has no hard contra-indication for antiplatelet therapy
•6) is between and including 18 and 80 years old
•7) is able and willing to give written informed consent

•A potential subject who meets any of the following criteria will be excluded
•from participation in this study:
•1) Any concurrent illness, disability or clinically significant abnormality
•that may as judged by the investigator, affect the interpretation of clinical
•efficacy or safety data or prevent the subject from safely completing the
•assessments required by the Clinical Investigation Plan.
•2) Current participation in another interventional clinical trial.
•3) Patient with insufficient arterial blood flow (judged by an experienced
•4) Patients with insufficient venous outflow and/or with obstructions (judged
•experienced clinician)
•5) History of anaphylaxis or severe allergic responses.
•6) Treatment with systemic immunosuppressant drugs or patients which are immune
•7) Women who are lactating, pregnant (positive pregnancy test at baseline) or
•planning to
•become pregnant during the course of the study.
•8) Signs of active infection, requiring systemic treatment or serious infection
•within the last
•3 months based on patient screening data.
•9) Poorly controlled diabetes mellitus (HbA1C > 75 mmol/mol Hb).
•10) Current substance abuse or alcohol abuse. 11) Presence of vitamin K
•antagonists.

发起方

VACIS B.V.