AVF Hemodialysis access
Conditions
Interventions
Patients will be implanted with a sterile VACIS Rod through a small skin
incision into the subcutis with the exact location to be determined by the
investigator, where it will stay for 28 days to fo
Sponsors
VACIS B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess using the created TC as an AV access. Furthermore, the use of the graft for hemodialysis will be studied for outcomes without unexpected adverse events attributable to the TC during a total of 12 weeks. The primary endpoint of the study is the proportion of patients without unexpected adverse events attributable to the VACIS Rod and the TC. | — |
Secondary
| Measure | Time frame |
|---|---|
| Demonstrate the functionality of these AV grafts for hemodialysis access - proportion of patients having functional dialysis cannulation - proportion of patients having sufficient hemostasis after hemodialysis cannulation To assess the 12 weeks patency of the TC as an autologous AV graft - The primary and secondary patency of the arteriovenous access graft 1. Primary patency: number of days the graft stays open during the duration of the trial without needing intervention (other than anti-coagulants) 2. Secondary patency: number of days the graft stays open during the duration of the trial after intervention (other than anti-coagulants) To assess the Tissue Capsule during this study on the objectives mentioned above - Amount and type of interventions needed to maintain patency during study participation - Qualitative assessment of the tissue capsule after 28 days by histology of the end caps - Frequency of bleeding, necrosis, and infection complications during the study participation - Time to hemostasis after removal of the dialysis needles - Frequency of aneurysms of the graft - Frequency of stenosis and/or intimal hyperplasia at the anastomosis sites | — |
Countries
Netherlands
Outcome results
None listed