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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47337

Enrollment

Registered

2019-01-28

Start date

2017-02-22

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysma

Interventions

Routine care consists of a preoperative and several postoperative CTA scans (at six weeks and one year following Gore IBE implantation). In A. The preoperative and first postoperative CTA will be re

Dynamic CT

endovascular treatment

Iliac aneurysm

Iliac branced device

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

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

Measure

Time frame

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

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)