Iliac Branch Device Movement During Cardiac Cycle (IBD-dynamics)

Rijnstate Hospital

Status: Completed

Conditions: Angiography; AAA; Iliac Aneurysm

Treatments: Radiation: ECG gated CTA

Study type: Interventional

Funder types: Other

Identifiers

NCT03762525

IBD-dynamics

Details and patient eligibility

About

The incidence of isolated common iliac artery (CIA) aneurysms is low, but in combination with an abdominal aortic aneurysm (AAA) they are found in approximately 20-40% of cases. Basically, two different endovascular strategies can be applied to treat a CIA aneurysm with, including 1. the coverage and 2. the preservation of blood flow to the internal iliac artery (IIA). Coil and coverage of the IIA is related to ischemic complications, including buttock claudication, erectile dysfunction and the more severe spinal and colonic ischemia. Iliac branched devices (IBD) have been developed to exclude CIA aneurysms preserving the IIA and currently three alternatives are on the market. Clinical results of these devices are promising but loss of patency is not uncommon. The major difference between the two devices is the IIA component. The Cook IBD uses a -non-dedicated IIA component, while in the GORE® EXCLUDER® Iliac Branch Endoprosthesis (Gore IBE device) a dedicated self expanding stent is used. Stresses and forces exerted onto the endograft by aortic pulsatility may have an effect on the durability and functioning of the endograft. Intermittent hinchpoints could also have an effect on stent integrity and stenosis. By evaluating endograft movement during the cardiac cycle (ECG-gated CTA) it is possible to assess the stress and force exerted onto the endograft. This might help gain insight into mechanisms underlying potential endograft failure, and aid procedural planning and the development of future devices with long-term durability.

The choice for device is not part of this study.

Full description

Objectives:To compare the mobility of the hypogastic artery during the cardiac cycle before and six weeks after implantation of the Gore IBE device in conjunction with its dedicated self expandable Internal Iliac component (Sub-study A);and to quantitatively characterize the displacement of stents with regard to the main body and native IIA during the cardiac cycle on an implanted iliac branched endograft in conjunction with a non-dedicated IIA component (Cook IBD with Advanta V12 or Fluency) with those in conjunction with a dedicated self expandable Internal Iliac component (Gore IBE device). (Sub-study B) Study design: Sub-study A & B: Multicenter observational case studies Study population: Sub-study A: 15 prospectively included patients and sub-study B: 15 patients in each group that have been treated in the period October 2006 - July 2016.

Enrollment: 45 patients

Sex: All

Volunteers: No Healthy Volunteers

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 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-January 2017.

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

ECG gated CTA pre and post operative at Gore IBE

Other group

Description:

To prospectively enroll 15 patients that are scheduled for endovascular aneurysm repair using the Gore IBE device in conjunction with its dedicated self expanding Internal Iliac component. Each patient will have an ECG gated CTA scan before the operation and 6-8 weeks after operation, in stead of a regular CT scan.

Treatment:

Radiation: ECG gated CTA

ECG gated CTA post operative at Gore IBE and Cook IBD

Other group

Description:

To compare 15 patients that have been treated in the period October 2006- July 2016 with the Cook IBD with a non-dedicated IIA component (Advanta-V12 or Fluency) and 15 matched patients treated with Gore IBE device. Each patient will have an ECG gated CTA after the operation, at the first doctor's appointment, in stead of a regular CT scan.

Treatment:

Radiation: ECG gated CTA