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CompletedNCT02692664TAILORUpdated Feb 17, 2026

Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft

An observational study in Iliac Aneurysm and AAA, sponsored by JOTEC GmbH. Completed at 2 sites in France. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by JOTEC GmbH · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
71
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Iliac Aneurysm
  • AAA

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Keywords

  • iliac side branch
03

In context

Iliac Aneurysm

30 studies on the registry are indexed under Iliac Aneurysm; 7 are open to participants now.

This study's enrollment of 71 is below the median of 100 across 12 observational studies indexed under Iliac Aneurysm.

Browse Iliac Aneurysm studies →

Lead sponsor

JOTEC GmbH is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Male and female patients with unilateral or bilateral common iliac aneurysm, treated with the E-liac Stent Graft System

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 from.

Exclusion criteria

Exclusion Criteria:

  • Patients who do not meet the instructions for use
  • Patients with one of the 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 \< 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 drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
  • Patient with needing chemotherapy or radiation
  • Patients with of less than 36 months
  • Patient minor or under guardianship
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
71 participants (actual)
Patient registry
No

Interventions

  • DeviceEndovascular aorto-iliac repair

    Also known as: EVAR

06

What researchers measure

Primary outcomes

  1. Clinical success

    Clinical success related to the E-liac Stent Graft combines the following criteria (adapted from Chaikof 2002): * Clinical success should be reported on an intent-to-treat Basis * requires successful deployment of the E-liac Stent Graft at the intended location without * Death as a result of iliac aneurysm-related treatment * Type I or III endoleak * E-liac Stent Graft infection * E-liac Stent Graft thrombosis (including internal iliac artery thrombosis) * Aneurysm growth \>3mm in maximum diameter for common iliac aneurysm and \>5mm in maximum diameter for aortic aneurysm at 12, 24, and 36 months follow-up * Common iliac aneurysm rupture * Conversion to open repair * Failure of E-liac Stent Graft integrity

    Time frame: 30 days follow-up

07

Study locations

2 sites
  • CHU Nantes
    Nantes, France
  • CHU Rennes
    Rennes, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02692664
Lead sponsor
JOTEC GmbH
Responsible party
Sponsor
First posted
Feb 26, 2016
Start date
May 1, 2016
Primary completion
Jul 5, 2024
Completion
Jul 5, 2024
Last update
Feb 17, 2026

Study contacts

Adrien Kaladji, Prof.
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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