arteriovenous shunt dialysis shunt
Conditions
Interventions
None listed
Sponsors
Zuyderland Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This proof of principle study aims to provide the safety and feasibility of OCT in patients with primary shunt failure requiring re-intervention. Safety is defined as conducting the OCT measurement without complications caused by the OCT measurement. Feasibility is defined as successfully completing the OCT measurement before and after PTA. The main question to be answered is: *Is OCT safe to use during PTA of AVF in patients with failure of the AVF in the Zuyderland Medical Center?* | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters: - The difference measured in millimeters between the estimated DSA-based and objective OCT-measured diameters of the vessel, including the stenosis. - Whether the surgeon would have selected the same type and size balloon based on the DSA images versus the OCT images. - Whether the OCT-measurement would have caused the surgeon to decide to carry on the procedure to reach a better outcome. - Whether OCT can capture the different effects of different types of balloons on the vessel wall | — |
Countries
Netherlands
Outcome results
None listed