NL-OMON51014WithdrawnNot Applicable
Study of a novel implantable device to generate an autologous vascular graft for hemodialysis access - VACIS Rod
VACIS B.V.0 sites20 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •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
- •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.
Investigators
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