Vascular remodeling after the creation of an arteriovenous fistula as angioaccess for hemodialysis: the predictive value of a patient-specific computer simulation model.

Completed

Conditions: Het al dan niet falen van een geschikte vaattoegang voor patienten die lijden aan terminaal nierfalen en die behandeld gaan worden met hemodialyse.
Maturation
AVF failure

Registration Number: NL-OMON31512

Lead Sponsor: Academisch Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

-Pre-dialysis patients with a detoriation of kidney function and an expected start with hemodialysis within three months and patients that are approved to receive a vascular access based on preoperative diagnostics.
-Dialysis patients for which it becomes necessary to create a new vascular access because the old vascular access has become useless for proper hemodialysis. In addition, the patients should be approved to receive a vascular access in the contralateral arm based on preoperative diagnostics.
- Only patients with an age of 18 years and older are included.
See also page 5 and 6 of the protocol.

Exclusion Criteria

-Standard contra-indications for CE-MRA (ferromagnetic implants that can possibly move, pacemakers or claustrofobia). For patients with such implants, we use Shellock's most updated manual to determine if we can make the scan or not.
-Possible or proved over-sensitivity for the Gadolinium containing contrast agent.
-If it is possible to do a revision of the already available vascular access.
- Patients younger than 18 years old.
See also page 6 of the protocol.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- A model that is able to predict the patient-specific postoperative flow with<br /><br>a maximum deviation of 10% compared to the<br /><br>measured postoperative flow.<br /><br>- A model for postoperative flow prediction that is clinically evaluated for 60<br /><br>patients.<br /><br>- A model that can predict long term patency of arteriovenous fistula by imput<br /><br>of patient specific parameters<br /><br>- A model that is able to predict hypoperfusion.<br /><br>- A model for hypoperfusion that is clinically evaluated for 60 patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- A measurement protocol to determine the vessel compliances by using<br /><br>ultrasound and blood measurements<br /><br>- A measurement protocol to determine the patient's geometry by using both<br /><br>non-contrast enhanced and contrast<br /><br>enhanced MRA.</p><br>