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OpenTrials
Completed

NCT Number: NCT02692664

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nantes, Nantes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovascular aorto-iliac repair

Device

Other names: EVAR

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

JOTEC GmbH

Industry

Registry information

Acronym: TAILOR

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2016
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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