Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched … (NCT02692664) | Clinical Trial Compass
CompletedNot Applicable
Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft
France71 participantsStarted 2016-05-01
Plain-language summary
In this study, patients will be observed who receive an E-liac Stent Graft for treatment of isolated iliac aneurysms or an E-liac Stent Graft in combination with one of the following AAA stent grafts: E-tegra Stent Graft, Endurant AAA Stent Graft, Zenith AAA Endovascular Graft, Gore Excluder AAA Endoprosthesis for treatment of aorto-iliac aneurysms.
Objectives of this post-market registry are:
Primary: To prevent the risk of rupture and death by the treatment of common iliac aneurysm with an iliac branched stent graft (E-liac, JOTEC) Secondary: Evaluation of safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aorto-iliac or iliac aneurysm.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Unilateral or bilateral aorto-iliac or iliac aneurysm
* Suitable for endovascular repair
* Patient must be compliant with life- long follow-up investigations
* \>18 years old
* lliac/femoral access vessel morphology compatible with the implantation procedure and the 18Fr (6mm OD) delivery system
* Non-aneurysmal common iliac artery landing area in case of iliac artery aneurysm ≥ 20mm
* Diameter of the common iliac artery in the proximal landing area: 12mm to 17mm
* Non-aneurysmal external iliac artery segment distal to the aneurysm ≥15mm
* Diameter of the external iliac artery in the distal landing area: 8mm to 13mm
* Non-aneurysmal internal iliac artery segment distal to the aneurysm ≥15mm
* Angle between external iliac artery and internal iliac artery ≤50°
* Thrombus free iliac lumen in the area of iliac bifurcation to open hypogastric side branch and to implant covered stent ≥18mm
* Sufficiently open internal iliac arterv ostium
* Patients must comply with the instructions for use.
* Patients with common iliac aneurysm with a diameter ≥30mm when isolated or common iliac aneurysm with a diameter \>25mm when associated with an abdominal aortic aneurysm
* Unilateral or bilateral common iliac aneurysm
* Patient's anatomy must be fit for stent graft placement on preoperative angio CT scan.
* Patient is affiliated to the social security or equivalent system.
* The patient must be available for the appropriate follow-up times for the duration of the study.
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.