NCT03762525

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

Completed NA Last updated 12 February 2021

What this trial tests

NA trial testing ECG gated CTA in Iliac Aneurysm in 45 participants. Completed in 31 December 2020.

Timeline

5 October 2016

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Rijnstate Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	45
Start date	5 October 2016
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	3 locations across Netherlands

Drugs / interventions tested

• ECG gated CTA

Conditions studied

• Iliac Aneurysm — all drugs for Iliac Aneurysm →
• Angiography — all drugs for Angiography →
• AAA — all drugs for AAA →

Sponsor

Rijnstate Hospital

Who can join

Eligibility, any sex, with Iliac Aneurysm or Angiography. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Differences in Cardiac-Pulsatility-Induced Displacement and Geometry Changes between the Cook ZBIS and Gore IBE: Postoperative Comparison Using ECG-Gated CTA Scans.
   Simmering JA, van Helvert M, van Herwaarden JA, Slump CH, et al · · 2023 · cited 3× · PMID 36766601 · DOI 10.3390/diagnostics13030496