AI-Powered Research

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
forearm
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

Exclusion Criteria

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
clinician)
4) Patients with insufficient venous outflow and/or with obstructions (judged
by an
experienced clinician)
5) History of anaphylaxis or severe allergic responses.
6) Treatment with systemic immunosuppressant drugs or patients which are immune
depressed.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Assess using the created TC as an AV access. Furthermore, the use of the graft<br /><br>for hemodialysis will be studied for outcomes without unexpected adverse events<br /><br>attributable to the TC during a total of 12 weeks. The primary endpoint of the<br /><br>study is the proportion of patients without unexpected adverse events<br /><br>attributable to the VACIS Rod and the TC.</p><br>

Secondary Outcome Measures