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

NCT ID: NCT03762525

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-05
• Study Completion Date: 2020-12-31

Brief Summary

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.

Detailed 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.

Conditions

Iliac Aneurysm; Angiography; AAA

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ECG gated CTA pre and post operative at Gore IBE

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.

Group Type: OTHER

ECG gated CTA

Intervention Type: RADIATION

Routine care consists of a preoperative and several postoperative CTA scans. In A. The preoperative and first postoperative CTA will be replaced by ECG-gated CTA imaging and in B. the scheduled imaging will be replaced by an ECG-gated CTA.

General information: The protocol is based on the ECG gated cardiac protocol using abdominal parameter settings.

ECG gated CTA post operative at Gore IBE and Cook IBD

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.

Group Type: OTHER

ECG gated CTA

Intervention Type: RADIATION

Routine care consists of a preoperative and several postoperative CTA scans. In A. The preoperative and first postoperative CTA will be replaced by ECG-gated CTA imaging and in B. the scheduled imaging will be replaced by an ECG-gated CTA.

General information: The protocol is based on the ECG gated cardiac protocol using abdominal parameter settings.

Interventions

ECG gated CTA

Routine care consists of a preoperative and several postoperative CTA scans. In A. The preoperative and first postoperative CTA will be replaced by ECG-gated CTA imaging and in B. the scheduled imaging will be replaced by an ECG-gated CTA.

General information: The protocol is based on the ECG gated cardiac protocol using abdominal parameter settings.

Intervention Type: RADIATION

Eligibility 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 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michel Reijnen

Prof. Dr., Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel Reijnen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Rijnstate Hospital

Arnhem, , Netherlands

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Elisabeth Tweesteden ziekenhuis

Tilburg, , Netherlands

Countries

Netherlands

Other Identifiers

IBD-dynamics

Identifier Type: -

Identifier Source: org_study_id