Endovascular Procedures Abdominal Aneurysm
Conditions
Interventions
The study is divided in 3 phases:
Phase 0: Radiation dose reduction and determination of the optimum reduced dose level. (20 patients for iliac and 20 for EVAR procedures, 40 in total)
Phase 1: Dou
Sponsors
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
5684 PC Best
The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: -Subject will be undergoing an EVAR or iliac/peripheral procedure -Subject is 18 years of age or older, or of legal age to give informed consent per national law
Exclusion criteria
Exclusion criteria: -Subject with contrast allergies -Subject with severe kidney disease (e-GFR <45 by Modification of Diet in Renal Disease (MDRD formula) -Subject participates in a potentially confounding drug or device trial during the course of the study. -Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman) -Subject with overt hyperthyroidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the amount of contrast medium required to perform iliac/peripheral and EVAR procedures using the AlluraClarity control settings and the study settings, at similar procedure complexity quantified as fluoro time, number of DSA images and number of DSA runs. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Demonstrate that study settings and diluted contrast medium injection protocols for DSA can be used for an entire procedure (i.e. prove that physician never switches back during the procedure to control settings and standard contrast medium injection protocol) -Evaluate the change in radiation dose required to minimize contrast medium usage for the new proposed study settings | — |
Contacts
Public ContactMehrsima Abdoli
Philips Medical Systems NL BV, Clinical Scientist
Outcome results
None listed