Anatomic dynamics of the internal iliac artery after placement of iliac branched devices using ECG-gated Computer Tomography Angiography imaging (CTA)<br>(IBD-dynamics)<br>

Completed

• Conditions: 10002363; Aneurysma

• Registration Number: NL-OMON47337
• Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-11
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 49

Inclusion Criteria

• Sub-study A. scheduled endovascular aneurysm repair using the Gore IBE device.
• Sub-study B. Patients that have been treated with an iliac branched device in the past (Oct 2006-May 2018) in conjunction with either a dedicated IIA component (Gore IBE device) or non-dedicated IIA component (Cook IBD) and who are scheduled for follow-up imaging within the period July 2016-December 2018.

Exclusion Criteria

No specific exclusion criteria. Patients will be treated according to the hospital*s standard practice.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To compare the mobility of the hypogastic artery during the cardiac cycle<br /><br>before and after implantation of the Gore IBE device (Sub-study A).<br /><br>2. To quantitatively characterize the displacement during the cardiac cycle on<br /><br>an implanted iliac branched endograft in conjunction with a non-dedicated n<br /><br>balloon expandable IIA component (Cook IBD with Advanta V12 or Fluency) with<br /><br>those in conjunction with a dedicated self expandable Internal Iliac cComponent<br /><br>(Gore IBE device). (Sub-study B).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Endpoints of the study will be;<br /><br>a. Displacement and angulation of the IIA component during the cardiac cycle<br /><br>compared to the native outflow vessel (Sub-study A)<br /><br>b. Displacement and angulation of the IIA component during the cardiac cycle<br /><br>compared to the main Gore IBE device/Cook IBD (Sub-study B)<br /><br>c. Tortuosity of the IIA component, defined as the difference between the<br /><br>highest angles of the central luminal line of the IIA component during the<br /><br>various phases. </p><br>