Iliac AneurysmTAILORNCT02692664
Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft
An observational study of Iliac Aneurysm and AAA, run by JOTEC GmbH at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Iliac Aneurysm, AAA
- What is being tested?
- Endovascular aorto-iliac repair
- Type of treatment
- Medical device
- How many people
- 71 participants
- Where
- 2 sitesFrance
- Study dates
- 1 May 2016to 5 Jul 2024
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients with unilateral or bilateral common iliac aneurysm, treated with the E-liac Stent Graft System
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
- Conditions
- Iliac Aneurysm, AAA
- Being tested
- Endovascular aorto-iliac repair
- Keywords
- iliac side branch
- Medical subject headings
- Iliac Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular aorto-iliac repairDevice
Also called EVAR
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study start1 May 2016
- Primary completion5 Jul 2024
- Study completion5 Jul 2024
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.
- More trials run by JOTEC GmbHThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrien Kaladji, Prof., Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692664
- Sponsor's protocol ID
- TAILOR
- Acronym
- TAILOR
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2016
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft
- ClinicalTrials.gov ID
- NCT02692664
- Acronym / sponsor ID
- TAILOR / TAILOR
- Conditions
- Iliac Aneurysm, AAA
- Keywords
- iliac side branch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- JOTEC GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 May 2016 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 26 Feb 2016 (estimated)
- 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients with unilateral or bilateral common iliac aneurysm, treated with the E-liac Stent Graft System
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
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 |
|---|---|---|
| Endovascular aorto-iliac repairAlso: EVAR | Device | – |
Primary outcome
Clinical success
Time frame: 30 days follow-up
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
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 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Adrien Kaladji, Prof. principal investigator
Rennes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iliac Aneurysm and AAA, run by JOTEC GmbH at 2 sites in France.
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 20 inclusion and 16 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Clinical success (time frame: 30 days follow-up). 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 17 Feb 2026.