New stent graft aims to fix aneurysms without major surgery
NCT ID NCT02692664
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a special stent graft (E-liac) to treat bulges in the iliac artery (aneurysms) without open surgery. 71 patients received the device, sometimes combined with other aortic grafts. The main goal was to prevent aneurysm rupture and death. Researchers tracked success by checking for complications like leaks, blockages, or aneurysm growth over 3 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- E-liac Stent Graft (a device placed inside blood vessels to repair aneurysms)
- What this could lead to
- If successful, this stent graft could offer a less invasive way to treat iliac aneurysms, reducing the need for open surgery.
- What could go wrong
- This is a small, completed registry study (71 patients) without a comparison group. Results may not apply to all patients, and risks like graft blockage or aneurysm growth remain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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71 people
The number who actually took part.
- Started
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May 2016
- Finished
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Jul 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Male and female patients with unilateral or bilateral common iliac aneurysm, treated with the E-liac Stent Graft System
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. * Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent from. Exclusion Criteria: * Patients who do not meet the instructions for use * Patients with one of the contraindications as indicated in the instructions for use * Patients with a stenotic internal iliac ostium of \< 4mm in Diameter * Patients with severe internal iliac atherosclerosis * Patients that do not have a suitable landing area in the main stem of the IIA (maximum diameter in landing area \<12mm) * Patients with pseudoaneurysms * Patients with symptomatic and ruptured iliac aneurysms * Patients pretreated with a AAA stent graft or a bifurcated vascular graft * Patient with thrombocytopenia * Patient with an estimated glomerular filtration rate \< 30 ml/min/1,73m2 immediately before the Intervention * Female of child bearing potential * In the lnvestigator's opinion patient has (a) eo-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements, or impact the scientific integrity of the study * Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints * Patient with malignancy needing chemotherapy or radiation * Patients with life expectancy of less than 36 months * Patient minor or under guardianship
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Nantes
Nantes, France
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CHU Rennes
Rennes, France
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Other studies related to the condition(s) this trial covers.