TAILOR: Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Unilateral or bilateral aorto-iliac or iliac aneurysm
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Suitable for endovascular repair
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Patient must be compliant with life- long follow-up investigations
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18 years old
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lliac/femoral access vessel morphology compatible with the implantation procedure and the 18Fr (6mm OD) delivery system
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Non-aneurysmal common iliac artery landing area in case of iliac artery aneurysm ≥ 20mm
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Diameter of the common iliac artery in the proximal landing area: 12mm to 17mm
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Non-aneurysmal external iliac artery segment distal to the aneurysm ≥15mm
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Diameter of the external iliac artery in the distal landing area: 8mm to 13mm
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Non-aneurysmal internal iliac artery segment distal to the aneurysm ≥15mm
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Angle between external iliac artery and internal iliac artery ≤50°
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Thrombus free iliac lumen in the area of iliac bifurcation to open hypogastric side branch and to implant covered stent ≥18mm
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Sufficiently open internal iliac arterv ostium
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Patients must comply with the instructions for use.
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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
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Unilateral or bilateral common iliac aneurysm
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Patient's anatomy must be fit for stent graft placement on preoperative angio CT scan.
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Patient is affiliated to the social security or equivalent system.
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The patient must be available for the appropriate follow-up times for the duration of the study.
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Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent from.
Exclusion Criteria:
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Patients who do not meet the instructions for use
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Patients with one of the contraindications as indicated in the instructions for use
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Patients with a stenotic internal iliac ostium of < 4mm in Diameter
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Patients with severe internal iliac atherosclerosis
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Patients that do not have a suitable landing area in the main stem of the IIA (maximum diameter in landing area <12mm)
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Patients with pseudoaneurysms
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Patients with symptomatic and ruptured iliac aneurysms
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Patients pretreated with a AAA stent graft or a bifurcated vascular graft
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Patient with thrombocytopenia
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Patient with an estimated glomerular filtration rate < 30 ml/min/1,73m2 immediately before the Intervention
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Female of child bearing potential
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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
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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
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Patient with malignancy needing chemotherapy or radiation
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Patients with life expectancy of less than 36 months
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Patient minor or under guardianship
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Nantes | Nantes | France |
Sponsors and Collaborators
- JOTEC GmbH
Investigators
- Principal Investigator: Adrien Kaladji, Dr., CHU Rennes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TAILOR