Optical Coherence Tomography in Arteriovenous Fistula Management: a proof of principle study

Conditions: arteriovenous shunt
dialysis shunt
10003216

Registration Number: NL-OMON53327

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Patients of any race or sex, and any age above 18 years
- Patients undergoing a PTA of an AVF
- Terminal kidney failure defined as an eGFR <15 ml/min
- Patients undergoing hemodialysis
- Patients who are able to provide informed consent

Exclusion Criteria

- Revascularization in the same AVF 30 days prior to the index procedure
- Non-maturated AVF
- Patients who have an AVG
- Known allergy to iodine contrast
- Pregnant patients
- PTA performed by a surgeon or interventional radiologist who is not trained
to use the OCT equipment

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This proof of principle study aims to provide the safety and feasibility of OCT<br /><br>in patients with primary shunt failure requiring re-intervention. Safety is<br /><br>defined as conducting the OCT measurement without complications caused by the<br /><br>OCT measurement. Feasibility is defined as successfully completing the OCT<br /><br>measurement before and after PTA.<br /><br><br /><br>The main question to be answered is: Is OCT safe to use during PTA of AVF in<br /><br>patients with failure of the AVF in the Zuyderland Medical Center?</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters:<br /><br>- The difference measured in millimeters between the estimated DSA-based and<br /><br>objective OCT-measured diameters of the vessel, including the stenosis.<br /><br>- Whether the surgeon would have selected the same type and size balloon based<br /><br>on the DSA images versus the OCT images.<br /><br>- Whether the OCT-measurement would have caused the surgeon to decide to carry<br /><br>on the procedure to reach a better outcome.<br /><br>- Whether OCT can capture the different effects of different types of balloons<br /><br>on the vessel wall</p><br>