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

Active, not recruiting

• Conditions: Iliac Aneurysm; AAA

• Registration Number: NCT02692664
• Lead Sponsor: JOTEC GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-26
• Study Start: 2016-04
• Primary Completion: 2021-07
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical success	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

Trial Locations

Locations (2)

CHU Nantes; 🇫🇷 Nantes, France

CHU Rennes; 🇫🇷 Rennes, France