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

NCT ID: NCT02692664

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2025-06-30

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Endovascular aorto-iliac repair

Intervention Type: DEVICE

Other Intervention Names

EVAR

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JOTEC GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrien Kaladji, Prof.

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

CHU Nantes

Nantes, , France

CHU Rennes

Rennes, , France

Countries

France

Other Identifiers

TAILOR

Identifier Type: -

Identifier Source: org_study_id