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

NCT02692664 | Completed

• 1 other identifier: TAILOR
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Iliac Aneurysm; AAA

Keywords

iliac side branch

Outcome Measures

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

  30 days follow-up

Interventions

Endovascular aorto-iliac repair DEVICE

Also known as: EVAR

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JOTEC GmbH: lead

Study Sites (2)

CHU Nantes

Nantes, France

Location

CHU Rennes

Rennes, France

Location

MeSH Terms

Conditions

Iliac Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Adrien Kaladji, Prof.

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: February 26, 2016
• Study Start: May 1, 2016
• Primary Completion: July 5, 2024
• Study Completion: July 5, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (2)