The objective of the study is to assess the use of the Tissue Capsule for AV grafting in renal failure patients and testing these AV grafts for hemodialysis access.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
A well-functioning arteriovenous (AV) access is the lifeline for dialysis
patients. The AV access that is created for this purpose has a limited life
span: next to the frequent puncturing there is a strong pressure component
affecting the AV access with risk of aneurysm. Once an AV access is no longer
functioning, a new AV access point has to be established. For this purpose,
VACIS has developed a novel technology which makes use of the foreign body
response to the VACIS Rod to create Tissue Capsules. These autologous Tissue
Capsules can serve as replacement for the current AV access technologies.
Study objective
The objective of the study is to assess the use of the Tissue Capsule for AV
grafting in renal failure patients and testing these AV grafts for hemodialysis
access.
Study design
This is an open-label, prospective, single center study.
Intervention
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 form the TC. The rod will be
implanted where the TC can be grafted to the artery and vein in-situ, after 28
days.
The VACIS Rod will be explanted 28 days after implantation and the tissue
capsule will be anastomosed for AV access for a 2 weeks graft maturation period
prior to hemodialysis cannulation.
Patients are followed for 10 weeks after graft maturation and start of
hemodialysis cannulation.
The graft maturation period of 2 weeks may be adjusted if approved by the
Principal Investigator.
Study burden and risks
The use of the VACIS Rod means a two-step procedure: first implanting the rod
and 28 days later grafting the TC in the vasculature. This is an additional
burden for the patient compared to the use of an artificial AV access.
The risks below may lead to failure of the TC for AV access and cause the
burden of a new procedure to establish an arteriovenous access using an
artificial AV access.
The risk for this trial is that the following events can happen:
* infection
* pain
* leaking anastomosis or graft
* lack of patency
* aneurysms
* thrombosis
* excessive bleeding
* scarring (comparable with the use of an artificial AV access)
The acute risk of thrombosis in the grafted TC is higher than for an artificial
AV access and requires additional medication; however, after a short period of
time an endothelial layer forms and the risk of thrombosis is reduced. The dual
antiplatelet therapy to prevent thrombosis during the first six weeks after
surgery has a slightly higher risk of causing bleeding than clopidogrel
monotherapy, which is standard care after creating arteriovenous access with an
AV access.
For non-terminal dialysis patients, an autologously grown AV access can provide
a main alternative to the use of non-autologous prosthetic implants (artificial
AV access). Prosthetic implants are associated with an increase in
postoperative interventions and the risk of vascular graft infection.
Therefore, these implants provide inferior results when compared to an
autologous AV access. Hence the use of an artificial AV access is only
considered when there are no autologous options available. The incidence of
postoperative interventions in patients with an artificial AV access in our
group is around 2 interventions per patient year.
Compared to the use of AV accesses, the TC is expected to have better
acceptance than non-autologous options, with a decreased risk of infection. The
postoperative intervention rate is expected to be on the same level as in
patients with an artificial AV access.
Lastly, the AV access created with the Tissue Capsule can be a life-saving
treatment option for terminal dialysis patients, as other options may not be
available anymore.
Gaetano Martinolaan 63-65
Maastricht 6229GS
NL
Gaetano Martinolaan 63-65
Maastricht 6229GS
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75486.042.20 |