Contrast Medium Reduction with AlluraClarity for Iliac/Peripheral and EVAR procedures

Phase 4

Completed

• Conditions: Endovascular aneurysm repair and iliac/peripheral procedure; 10003216

• Registration Number: NL-OMON47473
• Lead Sponsor: Philips

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 260

Inclusion Criteria

* Subject will be undergoing an EVAR or iliac/peripheral procedure
* Subject is 18 years of age or older

Exclusion Criteria

* Subject with contrast allergies
* Subject with severe kidney disease (e-GFR<45, determined by the 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The following endpoints will be measured in Phase 2:<br /><br>- The amount of contrast used for each subject will be measured as contrast<br /><br>medium volume, flow, concentration, iodine delivery rate, iodine load.<br /><br>- Procedure complexity is quantified as fluoroscopy time, number of DSA runs<br /><br>and number of DSA images<br /><br>- Physician switch-backs will be quantified by the amount of DSA runs performed<br /><br>with control settings during a procedure which is supposed to be performed with<br /><br>study settings in phase 2.<br /><br>- Patient radiation dose will be quantified as DAP fluoro, DAP exposure, total<br /><br>DAP, and Air Kerma </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>