NL-OMON51014
Withdrawn
N/A
Study of a novel implantable device to generate an autologous vascular graft for hemodialysis access - VACIS Rod
VACIS B.V.0 sites20 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- AVF
- Sponsor
- VACIS B.V.
- Enrollment
- 20
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •3\) is considered eligible for arteriovenous access surgery
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)
Outcomes
Primary Outcomes
Not specified
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