Iliac AneurysmNCT03762525
Iliac Branch Device Movement During Cardiac Cycle (IBD-dynamics)
A study testing ECG gated CTA in people with Iliac Aneurysm and Angiography, run by Rijnstate Hospital at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Iliac Aneurysm, Angiography, AAA
- What is being tested?
- ECG gated CTA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesNetherlands
- Study dates
- 5 Oct 2016to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No specific exclusion criteria. Patients will be treated according to the hospital's standard practice.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Rijnstate Hospital
Arnhem
Universitair Medisch Centrum Groningen
Groningen
Elisabeth Tweesteden ziekenhuis
Tilburg
About this study
Official title: Anatomic Dynamics of the Internal Iliac Artery After Placement of Iliac Branched Devices Using ECG-gated Computer Tomography Angiography Imaging (IBD-dynamics)
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.
Read the 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
- Being tested
- ECG gated CTA
- Medical subject headings
- Iliac Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG gated CTARadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| ECG gated CTA pre and post operative at Gore IBE | Other | 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. Receives: Radiation: ECG gated CTA |
| ECG gated CTA post operative at Gore IBE and Cook IBD | Other | 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. Receives: Radiation: ECG gated CTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility of hypogastric artery during cardiac cycle (sub study A)
The mobility of the hypogastic artery during the cardiac cycle before and after implantation of the Gore IBE device (Sub-study A). This will be measured at 15 patients by making an ECG gated CTA per and postoperative.
Measured: Up to 1 year follow-up
Characterize displacement during cardiac cycle (Sub Study B)
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). This will be measured by 30 patients (15 pt Cook IBD and 15 pt Gore IBE) an ECG gated CTA postoperative.
Measured: Up to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start5 Oct 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliac AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This study is designed as a multicenter prospective case series. 1. 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. 2. Tocompare 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Reijnen, Rijnstate Hospital
- Investigators
- Michel Reijnen, MD, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762525
- Sponsor's protocol ID
- IBD-dynamics
- Status last verified
- Feb 2021
- First submitted
- 5 Oct 2018
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomic Dynamics of the Internal Iliac Artery After Placement of Iliac Branched Devices Using ECG-gated Computer Tomography Angiography Imaging (IBD-dynamics)
- ClinicalTrials.gov ID
- NCT03762525
- Acronym / sponsor ID
- IBD-dynamics
- Conditions
- Iliac Aneurysm, Angiography, AAA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is designed as a multicenter prospective case series. 1. 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. 2. Tocompare 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.
| Arm | Type | Receives |
|---|---|---|
| ECG gated CTA pre and post operative at Gore IBE | Other | Radiation: ECG gated CTATo 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. |
| ECG gated CTA post operative at Gore IBE and Cook IBD | Other | Radiation: ECG gated CTATo 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- No specific exclusion criteria. Patients will be treated according to the hospital's standard practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG gated CTARoutine 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. | Radiation | ECG gated CTA post operative at Gore IBE and Cook IBD, ECG gated CTA pre and post operative at Gore IBE |
Primary outcome
Mobility of hypogastric artery during cardiac cycle (sub study A)
Time frame: Up to 1 year follow-up
The mobility of the hypogastic artery during the cardiac cycle before and after implantation of the Gore IBE device (Sub-study A). This will be measured at 15 patients by making an ECG gated CTA per and postoperative.
Characterize displacement during cardiac cycle (Sub Study B)
Time frame: Up to 1 year follow-up
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). This will be measured by 30 patients (15 pt Cook IBD and 15 pt Gore IBE) an ECG gated CTA postoperative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Iliac Aneurysm
Recruiting
Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
Thoracoabdominal Aortic Aneurysm, Endovascular Repair
RecruitingObservational study
Evaluation Of Cost-Effectiveness Of Iliac Branch Endoprostheses
Aorto-iliac Aneurysm
Active, not recruitingObservational study
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Peripheral Artery Disease, Popliteal Aneurysm
Recruiting
iHub Stent-Graft for Iliac Artery Aneurysms: Safety, Performance, and Effectiveness Study
Iliac Aneurysm, Aortic Aneurysm, Abdominal
RecruitingObservational study
Individual Patient Data Meta-Analysis of Prospective Studies of Patients Treated With the GORE® Iliac Branched Endoprosthesis
Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Reijnen, MD, PhD principal investigator
Principal Investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG gated CTA in people with Iliac Aneurysm and Angiography, run by Rijnstate Hospital at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility of hypogastric artery during cardiac cycle (sub study A) (time frame: Up to 1 year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.