Clinical trial NCT02692664: Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft
Official title: Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iliac Aneurysm
AAA
Keywords: iliac side branch
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
First posted: 2016-02-26
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Clinical success
timeFrame: 30 days follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Adrien Kaladji, Prof.
role: PRINCIPAL_INVESTIGATOR
References: